FDA.reportPublic FDA data

Ammonium Lactate

Product NDC
51672-1301
11-digit product format
516721301
Labeler code
51672
Product ID
51672-1301_38e5b035-6ea3-605e-e063-6294a90a7087
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonium Lactate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075883
Marketing category
ANDA
Marketing start
2003-04-10
Substance
AMMONIUM LACTATE
Active strength
120 mg/g
Pharmacologic classes
Acidifying Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ammonium Lactate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMMONIUM LACTATE120 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii67M901L9NQ
Rxcui543460

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1301-0Ammonium Lactate385 g in 1 BOTTLE, PLASTICCREAM3858
51672-1301-2Ammonium Lactate140 g in 1 TUBECREAM1408
51672-1301-2Ammonium Lactate1 in 1 CARTONCREAM18
51672-1301-4Ammonium Lactate2 in 1 CARTONCREAM28
51672-1301-4Ammonium Lactate140 g in 1 TUBECREAM1408

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1301-0GM - Gram51672-1301b5fa1882-d4f1-4e01-a2f5-34f3bc293f4212012-07-24
51672-1301-2GM - Gram51672-1301de135ead-9564-4e4f-8a3f-b686bf6adea712024-10-04
51672-1301-4GM - Gram51672-1301a148ad99-5bd0-4e0f-a744-ca5b34f0de6d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ammonium LactateACTIVE INGREDIENT67M901L9NQAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
Lactic acidACTIVE MOIETY33X04XA5ATAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
laureth-4INACTIVE INGREDIENT6HQ855798JAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
light mineral oilINACTIVE INGREDIENTN6K5787QVPAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
PEG-100 stearateINACTIVE INGREDIENTYD01N1999RAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RAMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1301AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 5 package rows20240922_9745b6ce-f532-4e80-b6e9-477ab9db4e30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543460ammonium lactate 12 % Topical CreamPSN9745b6ce-f532-4e80-b6e9-477ab9db4e308
543460ammonium lactate 120 MG/ML Topical CreamSCD9745b6ce-f532-4e80-b6e9-477ab9db4e308
543460ammonium lactate 12 % Topical CreamSY9745b6ce-f532-4e80-b6e9-477ab9db4e308
543460ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical CreamSY9745b6ce-f532-4e80-b6e9-477ab9db4e308
543460ammonium lactate 12 % Topical CreamPSN030e8bd1-0ff3-479f-aa77-16fab701a1115
543460ammonium lactate 120 MG/ML Topical CreamSCD030e8bd1-0ff3-479f-aa77-16fab701a1115
543460ammonium lactate 12 % Topical CreamSY030e8bd1-0ff3-479f-aa77-16fab701a1115
543460ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical CreamSY030e8bd1-0ff3-479f-aa77-16fab701a1115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1301-051672130100385 g in 1 BOTTLE, PLASTIC (51672-1301-0) 385 g2003-04-100000-00-00NoNoCurrent
51672-1301-2516721301021 TUBE in 1 CARTON (51672-1301-2) / 140 g in 1 TUBE1 tube2024-07-01NoNoCurrent
51672-1301-4516721301042 TUBE in 1 CARTON (51672-1301-4) / 140 g in 1 TUBE2 tube2003-04-100000-00-00NoNoCurrent