Ammonium Lactate

Sold as Lac-Hydrin. Every FDA application for this active ingredient: 2 branded and 8 generic.

As of Nov 15, 2026, FDA lists 10 applications for Ammonium Lactate (sold as Lac-Hydrin), first approved Apr 24, 1985, with 1 new use approved and 0 published complete response letters.

First approved: Apr 24, 1985
Applications: 10
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $25.7M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Ammonium Lactate	Part D	$25.7M	-5%	594,530

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

AMMONIUM LACTATE 12% CREAM: $0.065 per GMGeneric · +5% in a year
AMMONIUM LACTATE 12% LOTION: $0.072 per GMGeneric · +6% in a year

Clinical Trials

223 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Baseline Neuromuscular Performance and Responses to a Simulated Match in Young AthletesNeuromuscular Performance, Exercise-Induced Fatigue · Inonu University	Not applicable	Not yet recruiting	Nov 12, 2026
Prehospital mSOFA-Kit Decision Support for the Detection of Multiple Organ FailureMultiple Organ Failure, Critical Illness · University of Valladolid	Not applicable	Not yet recruiting	Nov 10, 2026
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean SectionPostpartum Hemorrhage, Uterine Atony · Shalamar Hospital	Not applicable	Not yet recruiting	Nov 6, 2026
Personalized Metabolic Nutrition Sepsis StudyPediatric Sepsis · University of Pittsburgh	Not applicable	Not yet recruiting	Nov 2, 2026
Lactate/Albumin Ratio and Mortality in Respiratory FailureAcute Respiratory Failure, Critical Illness · Kocaeli City Hospital	—	Recruiting	Nov 2, 2026
Evaluate Precision of the Test for Lactate in Capillary Whole Blood Specimens Using the i-STAT CG4+ Cartridge With the i-STAT 1 AnalyzerLactate · Abbott Point of Care	—	Not yet recruiting	Oct 30, 2026
Recovery Modalities and Application Sequence in Elite Female Basketball PlayersBasketball, Basketball Performance · Medipol University	Not applicable	Enrolling by invitation	Oct 27, 2026
A Study of hBMMSC Injection in Patients With aPAPAutoimmune Pulmonary Alveolar Proteinosis · Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.	Phase 2	Not yet recruiting	Oct 22, 2026

Applications

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


Apr 24, 1985	Lac-HydrinNDA 19155 · New active ingredient	Sun Pharm Inds Inc	20	Discontinued
Aug 29, 1996	Lac-HydrinNDA 20508 · New dosage form	Sun Pharm Inds Inc	5	Discontinued
May 1, 2002	Ammonium LactateANDA 75774	Padagis Israel	3	Marketed
Jun 11, 2002	Ammonium LactateANDA 75575	Watson Labs Inc	2	Discontinued
Apr 10, 2003	Ammonium LactateANDA 75883	Sun Pharma Canada	1	Marketed
May 28, 2004	Ammonium LactateANDA 76216	Sun Pharma Canada	0	Marketed
Jun 23, 2004	Ammonium LactateANDA 75570	Padagis Israel	1	Marketed
Feb 7, 2006	Ammonium LactateANDA 76829	Watson Labs Inc	0	Discontinued
Feb 12, 2026	Ammonium LactateANDA 217815	Zydus Lifesciences	0	Marketed
May 15, 2026	Ammonium LactateANDA 217758	Zydus Lifesciences	0	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