Home NDC 68682-112 Pimecrolimus
Product NDC 68682-112
11-digit product format 686820112
Labeler code 68682
Product ID 68682-112_e391204d-95f9-4c57-a0db-578bdd1b8bde
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pimecrolimus
Dosage form CREAM
Route TOPICAL
Labeler Oceanside Pharmaceuticals
Application NDA021302
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-11-26
Substance PIMECROLIMUS
Active strength 10 mg/g
Pharmacologic classes Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 N021302-001 ELIDEL PIMECROLIMUS 1% CREAM / TOPICAL AB RLD, RS 2001-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021302-001 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 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021302-001 ELIDEL 1% CREAM / TOPICAL AB RLD, RS 2001-12-13 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 2027-12-31 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 68682-112-03 Pimecrolimus 100 g in 1 TUBE CREAM 100 4 68682-112-03 Pimecrolimus 1 in 1 CARTON CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-112 PIMECROLIMUS CREAM [OCEANSIDE PHARMACEUTICALS] 3 Current NDC, Legacy NDC, 2 package rows 20201215_6601e43e-ce7d-446a-8568-8e7b24b86f06.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 68682-112-03 68682011203 1 TUBE in 1 CARTON (68682-112-03) / 100 g in 1 TUBE 1 tube 2018-11-26 0000-00-00 No No Current