Home NDC 51672-4188 Betamethasone Valerate
Product NDC 51672-4188
11-digit product format 516724188
Labeler code 51672
Product ID 51672-4188_4db5f987-1ae8-b673-e063-6294a90aedd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betamethasone Valerate
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA208204
Marketing category ANDA
Marketing start 2017-05-24
Substance BETAMETHASONE VALERATE
Active strength 1.2 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 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 A208204-001 BETAMETHASONE VALERATE BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208204-001 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 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB RS 2017-05-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208204-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2017-05-24 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETAMETHASONE VALERATE 1.2 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 1244634 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 51672-4188-3 Betamethasone Valerate 50 g in 1 CAN AEROSOL, FOAM 50 3 51672-4188-3 Betamethasone Valerate 1 in 1 CARTON AEROSOL, FOAM 1 3 51672-4188-7 Betamethasone Valerate 100 g in 1 CAN AEROSOL, FOAM 100 3 51672-4188-7 Betamethasone Valerate 1 in 1 CARTON AEROSOL, FOAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4188 BETAMETHASONE VALERATE AEROSOL, FOAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 Current NDC, Legacy NDC, 4 package rows 20170526_7c96b978-25ff-44c2-bc9c-30ff5e34cffb.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 51672-4188-3 51672418803 1 CAN in 1 CARTON (51672-4188-3) / 50 g in 1 CAN 1 can 2017-05-24 0000-00-00 No No Current 51672-4188-7 51672418807 1 CAN in 1 CARTON (51672-4188-7) / 100 g in 1 CAN 1 can 2017-05-24 0000-00-00 No No Current