Home NDC 51672-1316 Alclometasone Dipropionate
Product NDC 51672-1316
11-digit product format 516721316
Labeler code 51672
Product ID 51672-1316_3c44a51b-8abe-ceae-e063-6294a90a482c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alclometasone dipropionate
Dosage form OINTMENT
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076730
Marketing category ANDA
Marketing start 2004-07-29
Substance ALCLOMETASONE DIPROPIONATE
Active strength .5 mg/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 43 .
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 A076730-001 ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076730-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076730-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2004-07-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Alclometasone Dipropionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCLOMETASONE DIPROPIONATE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S56PQL4N1V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855480 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 51672-1316-1 Alclometasone Dipropionate 15 g in 1 TUBE OINTMENT 15 6 51672-1316-1 Alclometasone Dipropionate 1 in 1 CARTON OINTMENT 1 6 51672-1316-3 Alclometasone Dipropionate 60 g in 1 TUBE OINTMENT 60 6 51672-1316-3 Alclometasone Dipropionate 1 in 1 CARTON OINTMENT 1 6 51672-1316-5 Alclometasone Dipropionate 5 g in 1 TUBE OINTMENT 5 6 51672-1316-6 Alclometasone Dipropionate 45 g in 1 TUBE OINTMENT 45 6 51672-1316-6 Alclometasone Dipropionate 1 in 1 CARTON OINTMENT 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1316 ALCLOMETASONE DIPROPIONATE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Current NDC, Legacy NDC, 7 package rows 20250406_3b0dccd6-dee1-49dd-8c6d-82df5c7ee36c.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 51672-1316-1 51672131601 1 TUBE in 1 CARTON (51672-1316-1) / 15 g in 1 TUBE 1 tube 2004-07-29 0000-00-00 No No Current 51672-1316-3 51672131603 1 TUBE in 1 CARTON (51672-1316-3) / 60 g in 1 TUBE 1 tube 2004-07-29 0000-00-00 No No Current 51672-1316-5 51672131605 5 g in 1 TUBE (51672-1316-5) 5 g 2004-07-29 0000-00-00 No No Current 51672-1316-6 51672131606 1 TUBE in 1 CARTON (51672-1316-6) / 45 g in 1 TUBE 1 tube 2004-07-29 0000-00-00 No No Current