Ammonium Lactate

Product NDC
63629-8610
11-digit product format
636298610
Labeler code
63629
Product ID
63629-8610_00b2a93c-92de-90c6-e063-6294a90a6d33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonium Lactate
Dosage form
LOTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA075570
Marketing category
ANDA
Marketing start
2006-06-20
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8610-1Ammonium Lactate225 g in 1 BOTTLE, PLASTICLOTION225105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8610-1GM - Gram63629-86103eef66e1-464a-4188-9a52-79f96983ab8f12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8610AMMONIUM LACTATE LOTION [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20230718_1d2adae5-0225-4e66-8f4f-14a5ef11e1d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197362ammonium lactate 12 % Topical LotionPSN1d2adae5-0225-4e66-8f4f-14a5ef11e1d0105
197362ammonium lactate 120 MG/ML Topical LotionSCD1d2adae5-0225-4e66-8f4f-14a5ef11e1d0105
197362ammonium lactate 12 % Topical LotionSY1d2adae5-0225-4e66-8f4f-14a5ef11e1d0105
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSY1d2adae5-0225-4e66-8f4f-14a5ef11e1d0105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8610-163629861001225 g in 1 BOTTLE, PLASTIC (63629-8610-1) 225 g2006-06-200000-00-00NoNoCurrent