FDA.reportPublic FDA data

Ammonium Lactate

Product NDC
45802-419
11-digit product format
458020419
Labeler code
45802
Product ID
45802-419_6a24c09f-e06e-478f-9b67-4abe154e60ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ammonium Lactate
Dosage form
LOTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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
45802-419-26Ammonium Lactate400 g in 1 BOTTLE, PLASTICLOTION40010
45802-419-54Ammonium Lactate225 g in 1 BOTTLE, PLASTICLOTION22510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-419-26GM - Gram45802-419fd26caa3-ac12-4425-a3da-4e45b51d6eea12012-07-24
45802-419-54GM - Gram45802-4199bccf240-95bc-47ea-9002-d9ccb983e02512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMMONIUM LACTATEACTIVE INGREDIENT67M901L9NQAMMONIUM LACTATE LOTION [PERRIGO NEW YORK INC]4
LACTIC ACID, DL-ACTIVE MOIETY3B8D35Y7S4AMMONIUM LACTATE LOTION [PERRIGO NEW YORK INC]4
AMMONIUM LACTATEACTIVE INGREDIENT67M901L9NQAMMONIUM LACTATE LOTION [PHYSICIANS TOTAL CARE, INC.]1
LACTIC ACID, DL-ACTIVE MOIETY3B8D35Y7S4AMMONIUM LACTATE LOTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-419AMMONIUM LACTATE LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]9Current NDC, Legacy NDC, 2 package rows20220927_dc3a6462-0f2c-4306-b5ef-c7b47395e959.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
197362ammonium lactate 12 % Topical LotionPSN7a23d405-a48c-482f-9b28-6ae851ccefe3104
197362ammonium lactate 120 MG/ML Topical LotionSCD7a23d405-a48c-482f-9b28-6ae851ccefe3104
197362ammonium lactate 12 % Topical LotionSY7a23d405-a48c-482f-9b28-6ae851ccefe3104
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSY7a23d405-a48c-482f-9b28-6ae851ccefe3104
197362ammonium lactate 12 % Topical LotionPSN99a5db95-7b48-46f1-99c7-db1c9ea65681100
197362ammonium lactate 120 MG/ML Topical LotionSCD99a5db95-7b48-46f1-99c7-db1c9ea65681100
197362ammonium lactate 12 % Topical LotionSY99a5db95-7b48-46f1-99c7-db1c9ea65681100
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSY99a5db95-7b48-46f1-99c7-db1c9ea65681100
197362ammonium lactate 12 % Topical LotionPSNdc3a6462-0f2c-4306-b5ef-c7b47395e95910
197362ammonium lactate 120 MG/ML Topical LotionSCDdc3a6462-0f2c-4306-b5ef-c7b47395e95910
197362ammonium lactate 12 % Topical LotionSYdc3a6462-0f2c-4306-b5ef-c7b47395e95910
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSYdc3a6462-0f2c-4306-b5ef-c7b47395e95910
197362ammonium lactate 12 % Topical LotionPSNdc577a65-3330-4f29-9b4e-a18952ea11eb1
197362ammonium lactate 120 MG/ML Topical LotionSCDdc577a65-3330-4f29-9b4e-a18952ea11eb1
197362ammonium lactate 12 % Topical LotionSYdc577a65-3330-4f29-9b4e-a18952ea11eb1
197362ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical LotionSYdc577a65-3330-4f29-9b4e-a18952ea11eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-419-2645802041926400 g in 1 BOTTLE, PLASTIC (45802-419-26) 400 g2006-06-200000-00-00NoNoCurrent
45802-419-5445802041954225 g in 1 BOTTLE, PLASTIC (45802-419-54) 225 g2006-06-200000-00-00NoNoCurrent