Home NDC 51672-1269 BETAMETHASONE VALERATE
Product NDC 51672-1269
11-digit product format 516721269
Labeler code 51672
Product ID 51672-1269_40339862-869b-f954-e063-6294a90a9add
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betamethasone Valerate
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA072041
Marketing category ANDA
Marketing start 1988-01-06
Substance BETAMETHASONE VALERATE
Active strength 1 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 A072041-001 DERMABET BETAMETHASONE VALERATE EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072041-001 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 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072041-001 DERMABET EQ 0.1% BASE CREAM / TOPICAL AB 1988-01-06 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 VALERATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETAMETHASONE VALERATE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9IFA5XM7R2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197407 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 51672-1269-1 BETAMETHASONE VALERATE 15 g in 1 TUBE CREAM 15 6 51672-1269-1 BETAMETHASONE VALERATE 1 in 1 CARTON CREAM 1 6 51672-1269-6 BETAMETHASONE VALERATE 45 g in 1 TUBE CREAM 45 6 51672-1269-6 BETAMETHASONE VALERATE 1 in 1 CARTON CREAM 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Betamethasone Valerate ACTIVE INGREDIENT 9IFA5XM7R2 BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Betamethasone ACTIVE MOIETY 9842X06Q6M BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 ceteareth-15 INACTIVE INGREDIENT 867H4YOZ8Z BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 mineral oil INACTIVE INGREDIENT T5L8T28FGP BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 petrolatum INACTIVE INGREDIENT 4T6H12BN9U BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 polyethylene glycol 1000 INACTIVE INGREDIENT U076Q6Q621 BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R BETAMETHASONE VALERATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Betamethasone Valerate ACTIVE INGREDIENT 9IFA5XM7R2 BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 Betamethasone ACTIVE MOIETY 9842X06Q6M BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 CETETH-20 INACTIVE INGREDIENT I835H2IHHX BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 CHLOROCRESOL INACTIVE INGREDIENT 36W53O7109 BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 phosphoric acid INACTIVE INGREDIENT E4GA8884NN BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1 water INACTIVE INGREDIENT 059QF0KO0R BETAMETHASONE VALERATE CREAM [REBEL DISTRIBUTORS CORP.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1269 BETAMETHASONE VALERATE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] 5 Current NDC, Legacy NDC, 4 package rows 20250529_3c85be0f-2731-44f1-a18e-d3852d54846f.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 · 5 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 51672-1269-1 51672126901 1 TUBE in 1 CARTON (51672-1269-1) / 15 g in 1 TUBE 1 tube 1988-01-06 0000-00-00 No No Current 51672-1269-6 51672126906 1 TUBE in 1 CARTON (51672-1269-6) / 45 g in 1 TUBE 1 tube 1988-01-06 0000-00-00 No No Current