Ammonium Lactate

Product NDC
63044-404
11-digit product format
630440404
Labeler code
63044
Product ID
63044-404_e730958b-9e8f-43b8-bcb2-ccddab3d9448
Type
HUMAN OTC DRUG
Nonproprietary name
Ammonium Lactate
Dosage form
CREAM
Route
TOPICAL
Labeler
Nnodum Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-12-30
Marketing end
0000-00-00
Substance
AMMONIUM LACTATE
Active strength
17 g/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
63044-404-202019-10-21C16284748780-1956f9ecf-dc44-621f-e053-dbdaa90a74adAmmonium Lactate Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63044-404-20Ammonium Lactate140 g in 1 TUBECREAM1402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63044-404-20GM - Gram63044-40477cfeeb4-4a9c-49c5-90c9-043d792c70ac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMMONIUM LACTATEACTIVE INGREDIENT67M901L9NQAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
LACTIC ACIDACTIVE MOIETY33X04XA5ATAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4AMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
PROPYLENE OXIDEINACTIVE INGREDIENTY4Y7NYD4BKAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2AMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RAMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63044-404AMMONIUM LACTATE CREAM [NNODUM PHARMACEUTICALS]2Legacy NDC, 1 package rows20100101_34d21510-062e-40ab-b074-ae3a0dc65e68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543460ammonium lactate 12 % Topical CreamPSN34d21510-062e-40ab-b074-ae3a0dc65e682
543460ammonium lactate 120 MG/ML Topical CreamSCD34d21510-062e-40ab-b074-ae3a0dc65e682
543460ammonium lactate 12 % Topical CreamSY34d21510-062e-40ab-b074-ae3a0dc65e682
543460ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical CreamSY34d21510-062e-40ab-b074-ae3a0dc65e682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63044-404-2063044040420140 g in 1 TUBE140 gHistorical