Home NDC 51672-1301 Ammonium Lactate
Product NDC 51672-1301
11-digit product format 516721301
Labeler code 51672
Product ID 51672-1301_38e5b035-6ea3-605e-e063-6294a90a7087
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ammonium Lactate
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA075883
Marketing category ANDA
Marketing start 2003-04-10
Substance AMMONIUM LACTATE
Active strength 120 mg/g
Pharmacologic classes Acidifying Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075883-001 AMMONIUM LACTATE AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2003-04-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075883-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2003-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2003-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075883-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2003-04-10 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ammonium Lactate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMMONIUM LACTATE 120 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 67M901L9NQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 543460 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1301-0 Ammonium Lactate 385 g in 1 BOTTLE, PLASTIC CREAM 385 8 51672-1301-2 Ammonium Lactate 140 g in 1 TUBE CREAM 140 8 51672-1301-2 Ammonium Lactate 1 in 1 CARTON CREAM 1 8 51672-1301-4 Ammonium Lactate 2 in 1 CARTON CREAM 2 8 51672-1301-4 Ammonium Lactate 140 g in 1 TUBE CREAM 140 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ammonium Lactate ACTIVE INGREDIENT 67M901L9NQ AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Lactic acid ACTIVE MOIETY 33X04XA5AT AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 glycerin INACTIVE INGREDIENT PDC6A3C0OX AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 laureth-4 INACTIVE INGREDIENT 6HQ855798J AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 light mineral oil INACTIVE INGREDIENT N6K5787QVP AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 methylparaben INACTIVE INGREDIENT A2I8C7HI9T AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 PEG-100 stearate INACTIVE INGREDIENT YD01N1999R AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 polyoxyl 40 stearate INACTIVE INGREDIENT 13A4J4NH9I AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1301 AMMONIUM LACTATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 7 Current NDC, Legacy NDC, 5 package rows 20240922_9745b6ce-f532-4e80-b6e9-477ab9db4e30.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-1301-0 51672130100 385 g in 1 BOTTLE, PLASTIC (51672-1301-0) 385 g 2003-04-10 0000-00-00 No No Current 51672-1301-2 51672130102 1 TUBE in 1 CARTON (51672-1301-2) / 140 g in 1 TUBE 1 tube 2024-07-01 No No Current 51672-1301-4 51672130104 2 TUBE in 1 CARTON (51672-1301-4) / 140 g in 1 TUBE 2 tube 2003-04-10 0000-00-00 No No Current