Home NDC 51672-1300 Ammonium Lactate
Product NDC 51672-1300
11-digit product format 516721300
Labeler code 51672
Product ID 51672-1300_38e594a2-48af-5554-e063-6294a90a376e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ammonium Lactate
Dosage form LOTION
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076216
Marketing category ANDA
Marketing start 2004-05-28
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 A076216-001 AMMONIUM LACTATE AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076216-001 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 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076216-001 AMMONIUM LACTATE EQ 12% BASE LOTION / TOPICAL AB 2004-05-28 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 197362 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1300-5 Ammonium Lactate 225 g in 1 BOTTLE, PLASTIC LOTION 225 6 51672-1300-9 Ammonium Lactate 400 g in 1 BOTTLE, PLASTIC LOTION 400 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ammonium Lactate ACTIVE INGREDIENT 67M901L9NQ AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 lactic acid ACTIVE MOIETY 33X04XA5AT AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 laureth-4 INACTIVE INGREDIENT 6HQ855798J AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 light mineral oil INACTIVE INGREDIENT N6K5787QVP AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 peg-100 stearate INACTIVE INGREDIENT YD01N1999R AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 polyoxyl 40 stearate INACTIVE INGREDIENT 13A4J4NH9I AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1300 AMMONIUM LACTATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240113_8bb09bb3-5bbc-489d-96c1-ae97cb58381e.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 51672-1300-5 51672130005 225 g in 1 BOTTLE, PLASTIC (51672-1300-5) 225 g 2004-05-28 0000-00-00 No No Current 51672-1300-9 51672130009 400 g in 1 BOTTLE, PLASTIC (51672-1300-9) 400 g 2004-05-28 0000-00-00 No No Current