Home NDC 45802-493-83 Ammonium Lactate
Product NDC 45802-493
Requested package NDC 45802-493-83
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45802-493 45802-493-83 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45802-493 45802-493-83 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A075774-001 AMMONIUM LACTATE AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2002-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075774-001 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 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2002-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB 2002-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075774-001 AMMONIUM LACTATE EQ 12% BASE CREAM / TOPICAL AB RS 2002-05-01 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 12 g/100g
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 45802-493-26 Ammonium Lactate 385 g in 1 BOTTLE, PUMP CREAM 385 13 45802-493-38 Ammonium Lactate 385 g in 1 BOTTLE CREAM 385 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-493 AMMONIUM LACTATE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] 11 Current NDC, Legacy NDC, 2 package rows 20250429_7096d38e-2bd1-4374-9bf6-7fd09ef7509c.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 · 4 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 45802-493-83 45802049383 2 TUBE in 1 CARTON (45802-493-83) > 140 g in 1 TUBE 2 tube 2007-01-25 0000-00-00 No No Current