Ammonium Lactate

Product NDC
63629-8608
11-digit product format
636298608
Labeler code
63629
Product ID
63629-8608_f9b57c62-5ff4-4103-b5d7-dc22792c0e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonium Lactate
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA075774
Marketing category
ANDA
Marketing start
2006-08-16
Substance
AMMONIUM LACTATE
Active strength
12 g/100g
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 LACTATE12 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii67M901L9NQ
Rxcui543460

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8608-1Ammonium Lactate2 in 1 CARTONCREAM2104
63629-8608-1Ammonium Lactate140 g in 1 TUBECREAM140104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8608-1GM - Gram63629-8608b45e6dd1-db92-492c-beb7-0c3a3feb161012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8608AMMONIUM LACTATE CREAM [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240415_170f8764-a180-49fa-b406-44f5b7921a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
543460ammonium lactate 12 % Topical CreamPSN170f8764-a180-49fa-b406-44f5b7921a66104
543460ammonium lactate 120 MG/ML Topical CreamSCD170f8764-a180-49fa-b406-44f5b7921a66104
543460ammonium lactate 12 % Topical CreamSY170f8764-a180-49fa-b406-44f5b7921a66104
543460ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical CreamSY170f8764-a180-49fa-b406-44f5b7921a66104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8608-1636298608012 TUBE in 1 CARTON (63629-8608-1) / 140 g in 1 TUBE2 tube2021-07-090000-00-00NoNoCurrent