Home NDC 51672-1309 Betamethasone Dipropionate
Product NDC 51672-1309
11-digit product format 516721309
Labeler code 51672
Product ID 51672-1309_38f65f63-5416-f33d-e063-6294a90a4238
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betamethasone Dipropionate
Dosage form GEL
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA076508
Marketing category ANDA
Marketing start 2003-12-02
Substance BETAMETHASONE 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 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 A076508-001 BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076508-001 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 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076508-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE GEL, AUGMENTED / TOPICAL AB 2003-12-02 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 Betamethasone Dipropionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETAMETHASONE 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 826Y60901U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 848208 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 51672-1309-1 Betamethasone Dipropionate 15 g in 1 TUBE GEL 15 6 51672-1309-1 Betamethasone Dipropionate 1 in 1 CARTON GEL 1 6 51672-1309-3 Betamethasone Dipropionate 1 in 1 CARTON GEL 1 6 51672-1309-3 Betamethasone Dipropionate 50 g in 1 TUBE GEL 50 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1309 BETAMETHASONE DIPROPIONATE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 4 package rows 20241222_e041ceb2-8bda-4703-b663-804e7b462e32.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 51672-1309-1 51672130901 1 TUBE in 1 CARTON (51672-1309-1) / 15 g in 1 TUBE 1 tube 2003-12-02 0000-00-00 No No Current 51672-1309-3 51672130903 1 TUBE in 1 CARTON (51672-1309-3) / 50 g in 1 TUBE 1 tube 2003-12-02 0000-00-00 No No Current