FDA.reportPublic FDA data

Ammonium Lactate

Product NDC
51672-1300
11-digit product format
516721300
Labeler code
51672
Product ID
51672-1300_38e594a2-48af-5554-e063-6294a90a376e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonium Lactate
Dosage form
LOTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076216
Marketing category
ANDA
Marketing start
2004-05-28
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
Rxcui197362

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51672-1300-52023-02-08C16284748780-1f386c649-ee8f-0266-e053-dadaa90a7c1aAmmonium Lactate Lotion 12%*
51672-1300-92023-02-08C16284748780-1f386c649-ee8f-0266-e053-dadaa90a7c1aAmmonium Lactate Lotion 12%*
51672-1300-52023-01-30C16284748780-1f386c649-ee8f-0266-e053-dadaa90a7c1aAmmonium Lactate Lotion 12%*
51672-1300-92023-01-30C16284748780-1f386c649-ee8f-0266-e053-dadaa90a7c1aAmmonium Lactate Lotion 12%*

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1300-5Ammonium Lactate225 g in 1 BOTTLE, PLASTICLOTION2256
51672-1300-9Ammonium Lactate400 g in 1 BOTTLE, PLASTICLOTION4006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1300-5GM - Gram51672-1300f3e5b834-7369-4e84-9ce1-821a26e0aa2512012-07-24
51672-1300-9GM - Gram51672-1300e7b6d29c-e373-44ab-a3cb-3ad3b3cee0d712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ammonium LactateACTIVE INGREDIENT67M901L9NQAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
lactic acidACTIVE MOIETY33X04XA5ATAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
laureth-4INACTIVE INGREDIENT6HQ855798JAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
light mineral oilINACTIVE INGREDIENTN6K5787QVPAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
peg-100 stearateINACTIVE INGREDIENTYD01N1999RAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RAMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1300AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 2 package rows20240113_8bb09bb3-5bbc-489d-96c1-ae97cb58381e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197362ammonium lactate 12 % Topical LotionPSN8bb09bb3-5bbc-489d-96c1-ae97cb58381e6
197362ammonium lactate 120 MG/ML Topical LotionSCD8bb09bb3-5bbc-489d-96c1-ae97cb58381e6
197362ammonium lactate 12 % Topical LotionSY8bb09bb3-5bbc-489d-96c1-ae97cb58381e6
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSY8bb09bb3-5bbc-489d-96c1-ae97cb58381e6
197362ammonium lactate 12 % Topical LotionPSNab54704d-ace2-410c-b0af-2fa13462a8b33
197362ammonium lactate 120 MG/ML Topical LotionSCDab54704d-ace2-410c-b0af-2fa13462a8b33
197362ammonium lactate 12 % Topical LotionSYab54704d-ace2-410c-b0af-2fa13462a8b33
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSYab54704d-ace2-410c-b0af-2fa13462a8b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1300-551672130005225 g in 1 BOTTLE, PLASTIC (51672-1300-5) 225 g2004-05-280000-00-00NoNoCurrent
51672-1300-951672130009400 g in 1 BOTTLE, PLASTIC (51672-1300-9) 400 g2004-05-280000-00-00NoNoCurrent