Home NDC 50090-6587 Ammonium Lactate
Product NDC 50090-6587
11-digit product format 500906587
Labeler code 50090
Product ID 50090-6587_261e2c03-7495-4a76-aebe-8e7c795cb8e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ammonium Lactate
Dosage form LOTION
Route TOPICAL
Labeler A-S Medication Solutions
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 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-6587-0 Ammonium Lactate 225 g in 1 BOTTLE, PLASTIC LOTION 225 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6587 AMMONIUM LACTATE LOTION [A-S MEDICATION SOLUTIONS] 3 Current NDC, 1 package rows 20230825_ab54704d-ace2-410c-b0af-2fa13462a8b3.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 Sample Exclude flag Status 50090-6587-0 50090658700 225 g in 1 BOTTLE, PLASTIC (50090-6587-0) 225 g 2023-08-10 No No Current