Home NDC 0591-2944 pimecrolimus
Product NDC 0591-2944
11-digit product format 005912944
Labeler code 0591
Product ID 0591-2944_a3f0bc92-796c-4f74-8c7a-63001b4e9e43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pimecrolimus
Dosage form CREAM
Route TOPICAL
Labeler Actavis Pharma, Inc.
Application ANDA209345
Marketing category ANDA
Marketing start 2018-12-27
Substance PIMECROLIMUS
Active strength 10 mg/g
Pharmacologic classes Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [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 1 .
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 A209345-001 PIMECROLIMUS PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209345-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209345-001 PIMECROLIMUS 1% CREAM / TOPICAL AB 2018-12-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base pimecrolimus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIMECROLIMUS 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7KYV510875 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 562806 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 0591-2944-30 pimecrolimus 30 g in 1 TUBE CREAM 30 5 0591-2944-60 pimecrolimus 60 g in 1 TUBE CREAM 60 5 0591-2944-87 pimecrolimus 100 g in 1 TUBE CREAM 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-2944 PIMECROLIMUS CREAM [ACTAVIS PHARMA, INC.] 5 Current NDC, Legacy NDC, 3 package rows 20181229_d5b0403a-065f-42e3-96d6-7dcb9ab127d3.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 · 1 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 0591-2944-30 00591294430 30 g in 1 TUBE (0591-2944-30) 30 g 2018-12-27 0000-00-00 No No Current 0591-2944-60 00591294460 60 g in 1 TUBE (0591-2944-60) 60 g 2018-12-27 0000-00-00 No No Current 0591-2944-87 00591294487 100 g in 1 TUBE (0591-2944-87) 100 g 2018-12-27 0000-00-00 No No Current