Butorphanol Tartrate

Sold as Stadol Preservative Free, Stadol. Every FDA application for this active ingredient: 2 branded and 14 generic.

As of Nov 15, 2026, FDA lists 16 applications for Butorphanol Tartrate (sold as Stadol Preservative Free, Stadol), first approved Aug 22, 1978, with 3 new uses approved and 0 published complete response letters.

First approved: Aug 22, 1978
Applications: 16
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $1.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Butorphanol Tartrate	Part D	$1.9M	-5%	2,479
Butorphanol Tartrate	Part B	$4K	+175%	127

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

BUTORPHANOL 10 MG/ML SPRAY: $15.54 per MLGeneric · -3% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Butorphanol for Pain Relief After Cesarean Section: A Retrospective StudyCaesarean Section · Sichuan Provincial People's Hospital	—	Not yet recruiting	Sep 16, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Aug 22, 1978	Stadol Preservative Free, StadolNDA 17857 · New molecular entity	Apothecon	44	Discontinued
Dec 12, 1991	StadolNDA 19890 · New dosage form	Bristol Myers Squibb	16	Discontinued
Jan 22, 1997	Butorphanol Tartrate Preservative FreeANDA 74620	Hospira	2	Discontinued
Jan 23, 1997	Butorphanol Tartrate Preservative FreeANDA 74626	Hospira	22	Marketed
Aug 12, 1998	Butorphanol Tartrate Preservative FreeANDA 75045	Hikma	7	Marketed
Aug 12, 1998	Butorphanol TartrateANDA 75046	Hikma	7	Marketed
Sep 28, 1998	Butorphanol Tartrate Preservative FreeANDA 75170	Hospira	8	Discontinued
Nov 4, 1999	Butorphanol TartrateANDA 75342	Hospira	0	Discontinued
Mar 20, 2000	Butorphanol TartrateANDA 75559	Hospira	4	Discontinued
Aug 8, 2001	Butorphanol TartrateANDA 75759	Rising	17	Discontinued
Oct 23, 2001	Butorphanol Tartrate Preservative FreeANDA 75695	Baxter Hlthcare Corp	5	Discontinued
Oct 23, 2001	Butorphanol TartrateANDA 75697	Baxter Hlthcare Corp	4	Discontinued
Mar 12, 2002	Butorphanol TartrateANDA 75824	Hikma	11	Marketed
Dec 4, 2002	Butorphanol TartrateANDA 75499	Apotex	16	Marketed
Apr 29, 2009	Butorphanol TartrateANDA 78247	Hikma Farmaceutica	6	Discontinued
May 1, 2009	Butorphanol TartrateANDA 78400	Hikma Farmaceutica	6	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA