FDA.reportPublic FDA data

Ammonium Lactate

Product NDC
45802-493
11-digit product format
458020493
Labeler code
45802
Product ID
45802-493_560c1e68-ccf1-4727-9838-30e4f17aef0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonium Lactate
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ammonium Lactate
Listing expiration
2027-12-31

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
45802-493-26Ammonium Lactate385 g in 1 BOTTLE, PUMPCREAM38513
45802-493-38Ammonium Lactate385 g in 1 BOTTLECREAM38513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-493-26GM - Gram45802-493c92a773a-a9fa-4287-919c-6dde31935bb812012-07-24
45802-493-38GM - Gram45802-49385d50c56-0123-469f-a735-ed57c73148ae12026-04-20
45802-493-83GM - Gram45802-493204fa34a-03c7-4c34-b603-c940f9b5139612012-07-24
45802-493-98GM - Gram45802-493d44fb9cf-fd38-4fd6-b4a7-b8b9d81984b012015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMMONIUM LACTATEACTIVE INGREDIENT67M901L9NQAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
LACTIC ACIDACTIVE MOIETY33X04XA5ATAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4AMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
LAURETH-4INACTIVE INGREDIENT6HQ855798JAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6
WATERINACTIVE INGREDIENT059QF0KO0RAMMONIUM LACTATE CREAM [PERRIGO NEW YORK INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-493AMMONIUM LACTATE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]11Current NDC, Legacy NDC, 2 package rows20250429_7096d38e-2bd1-4374-9bf6-7fd09ef7509c.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
543460ammonium lactate 12 % Topical CreamPSN2455f1aa-562d-424a-9542-4853adf1ca75103
543460ammonium lactate 120 MG/ML Topical CreamSCD2455f1aa-562d-424a-9542-4853adf1ca75103
543460ammonium lactate 12 % Topical CreamSY2455f1aa-562d-424a-9542-4853adf1ca75103
543460ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical CreamSY2455f1aa-562d-424a-9542-4853adf1ca75103
543460ammonium lactate 12 % Topical CreamPSN411b40c7-4d62-4ea4-be69-bea5d1d591ca100
543460ammonium lactate 120 MG/ML Topical CreamSCD411b40c7-4d62-4ea4-be69-bea5d1d591ca100
543460ammonium lactate 12 % Topical CreamSY411b40c7-4d62-4ea4-be69-bea5d1d591ca100
543460ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical CreamSY411b40c7-4d62-4ea4-be69-bea5d1d591ca100
543460ammonium lactate 12 % Topical CreamPSN7096d38e-2bd1-4374-9bf6-7fd09ef7509c13
543460ammonium lactate 120 MG/ML Topical CreamSCD7096d38e-2bd1-4374-9bf6-7fd09ef7509c13
543460ammonium lactate 12 % Topical CreamSY7096d38e-2bd1-4374-9bf6-7fd09ef7509c13
543460ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical CreamSY7096d38e-2bd1-4374-9bf6-7fd09ef7509c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-493-2645802049326385 g in 1 BOTTLE, PUMP (45802-493-26) 385 g2007-02-190000-00-00NoNoCurrent
45802-493-3845802049338385 g in 1 BOTTLE (45802-493-38) 385 g2026-03-16NoNoHistorical
45802-493-83458020493832 TUBE in 1 CARTON (45802-493-83) > 140 g in 1 TUBE2 tube2007-01-250000-00-00NoNoCurrent
45802-493-9845802049398140 g in 1 TUBE (45802-493-98) 140 g2006-08-160000-00-00NoNoCurrent