Home NDC 51672-4166 Clocortolone Pivalate
Product NDC 51672-4166
11-digit product format 516724166
Labeler code 51672
Product ID 51672-4166_0b06ddbb-6100-464f-9266-ace704fe8a40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clocortolone Pivalate
Dosage form CREAM
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., inc.
Application ANDA206370
Marketing category ANDA
Marketing start 2020-04-21
Substance CLOCORTOLONE PIVALATE
Active strength .001 g/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 A206370-001 CLOCORTOLONE PIVALATE CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206370-001 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.
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 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL 2020-04-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL 2020-04-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL 2020-04-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL 2020-04-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206370-001 CLOCORTOLONE PIVALATE 0.1% CREAM / TOPICAL AB 2020-04-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Clocortolone Pivalate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOCORTOLONE PIVALATE .001 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QBL8IZH14X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197520 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 51672-4166-6 Clocortolone Pivalate 1 in 1 CARTON CREAM 1 2 51672-4166-6 Clocortolone Pivalate 45 g in 1 TUBE CREAM 45 2 51672-4166-8 Clocortolone Pivalate 90 g in 1 TUBE CREAM 90 2 51672-4166-8 Clocortolone Pivalate 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4166 CLOCORTOLONE PIVALATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 Current NDC, Legacy NDC, 4 package rows 20220617_88d9a7cf-31b5-4b85-9827-0ecce328e6a0.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 51672-4166-6 51672416606 1 TUBE in 1 CARTON (51672-4166-6) / 45 g in 1 TUBE 1 tube 2020-04-21 0000-00-00 No No Current 51672-4166-8 51672416608 1 TUBE in 1 CARTON (51672-4166-8) / 90 g in 1 TUBE 1 tube 2020-04-21 0000-00-00 No No Current