NDA 16964, held by Hospira. Bupivacaine Hydrochloride, Bupivacaine Hydrochloride; Epinephrine Bitartrate.
As of Nov 13, 2026, NDA 16964 (Marcaine Hydrochloride, Marcaine Hydrochloride W/ Epinephrine, Marcaine Hydrochloride Preservative Free), held by Hospira, was first approved by FDA on Oct 3, 1972, with 52 approved supplements and 0 published complete response letters.
MARCAINE / MARCAINE WITH EPINEPHRINE is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of MARCAINE / MARCAINE WITH EPINEPHRINE are recommended for each type of block indicated to produce local or regional anesthesia or analgesia. Limitations of Use Not all blocks are indicated for use with MARCAINE / MARCAINE WITH EPINEPHRINE given clinically significant risks associated with use.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 3, 1972 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Marcaine Hydrochloride0.25% · injectable;injection | Bupivacaine Hydrochloride | RxReference drug |
| Marcaine Hydrochloride W/ Epinephrine0.25%;0.0091MG/ML · injectable;injection | Bupivacaine Hydrochloride; Epinephrine Bitartrate | RxReference drug |
| Marcaine Hydrochloride Preservative Free0.5% · injectable;injection | Bupivacaine Hydrochloride | RxReference drug |
| Marcaine Hydrochloride0.5% · injectable;injection | Bupivacaine Hydrochloride | RxReference drug |
| Marcaine Hydrochloride W/ Epinephrine Preservative Free0.5%;0.0091MG/ML · injectable;injection | Bupivacaine Hydrochloride; Epinephrine Bitartrate | RxReference drug |
| Marcaine Hydrochloride W/ Epinephrine0.5%;0.0091MG/ML · injectable;injection | Bupivacaine Hydrochloride; Epinephrine Bitartrate | RxReference drug |
| Marcaine Hydrochloride Preservative Free0.75% · injectable;injection | Bupivacaine Hydrochloride | RxReference drug |
| Marcaine Hydrochloride W/ Epinephrine Preservative Free0.75%;0.0091MG/ML · injectable;injection | Bupivacaine Hydrochloride; Epinephrine Bitartrate | RxReference drug |
| Marcaine Hydrochloride Preservative Free0.25% · injectable;injection | Bupivacaine Hydrochloride | RxReference drug |
| Marcaine Hydrochloride W/ Epinephrine Preservative Free0.25%;0.0091MG/ML · injectable;injection | Bupivacaine Hydrochloride; Epinephrine Bitartrate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 21, 2020 | Supplement 82Labeling · Standard review | Approved | |
| Nov 2, 2018 | Supplement 77Labeling · Standard review | Approved | |
| Dec 15, 2014 | Supplement 73Manufacturing · Priority review | Approved | None posted |
| Sep 19, 2014 | Supplement 72Manufacturing · Priority review | Approved | None posted |
| Jul 30, 2013 | Supplement 71Manufacturing · Priority review | Approved | None posted |
| Jan 30, 2012 | Supplement 70Labeling · Standard review | Approved | |
| Feb 19, 2010 | Supplement 69Labeling | Approved | |
| Oct 30, 2005 | Supplement 61Labeling · Standard review | Approved | |
| Jan 31, 2001 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Mar 11, 1999 | Supplement 52Labeling · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 51Labeling · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 48Labeling · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 46Labeling | Approved | None posted |
| Apr 9, 1997 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Jan 25, 1993 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| Aug 8, 1991 | Supplement 45Labeling | Approved | None posted |
| Feb 6, 1991 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Feb 6, 1991 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Apr 27, 1988 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Sep 15, 1987 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Jul 13, 1987 | Supplement 41Labeling | Approved | None posted |
| Jan 27, 1987 | Supplement 39Labeling | Approved | None posted |
| Jan 27, 1987 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Sep 11, 1985 | Supplement 35Labeling | Approved | None posted |
| Aug 24, 1985 | Supplement 37Labeling | Approved | None posted |
| Aug 19, 1985 | Supplement 36Labeling | Approved | None posted |
| May 20, 1985 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Mar 2, 1984 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Dec 1, 1983 | Supplement 34Labeling | Approved | None posted |
| Nov 21, 1983 | Supplement 24Labeling | Approved | None posted |
| Jul 13, 1983 | Supplement 29Labeling | Approved | None posted |
| Jul 13, 1983 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Jan 21, 1983 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Jan 27, 1982 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Dec 28, 1981 | Supplement 23Labeling | Approved | None posted |
| Aug 21, 1981 | Supplement 22Labeling | Approved | None posted |
| Aug 21, 1981 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Nov 3, 1980 | Supplement 19Labeling | Approved | None posted |
| Aug 21, 1980 | Supplement 15Labeling | Approved | None posted |
| Aug 21, 1980 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Dec 6, 1979 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Jun 18, 1979 | Supplement 17Labeling | Approved | None posted |
| Apr 4, 1979 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Apr 4, 1979 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jun 15, 1978 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Jun 15, 1978 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Nov 30, 1976 | Supplement 7Labeling | Approved | None posted |
| Jul 7, 1976 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jun 10, 1976 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jun 10, 1976 | Supplement 4Labeling | Approved | None posted |
| Jun 7, 1976 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jan 13, 1976 | Supplement 3Labeling | Approved | None posted |
| Oct 3, 1972 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
