Home NDC 51672-1390 Betamethasone dipropionate
Product NDC 51672-1390
11-digit product format 516721390
Labeler code 51672
Product ID 51672-1390_39628349-b360-4030-e063-6394a90a6ce9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betamethasone dipropionate
Dosage form SPRAY
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA211722
Marketing category ANDA
Marketing start 2020-06-17
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 A211722-001 BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17
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 2026-08-18 06:07:40 2026-07 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211722-001 BETAMETHASONE DIPROPIONATE EQ 0.05% BASE/SPRAY SPRAY / TOPICAL 2020-06-17 a50c72e98297…
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 1738536 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 51672-1390-4 Betamethasone dipropionate 60 g in 1 BOTTLE SPRAY 60 2 51672-1390-4 Betamethasone dipropionate 1 in 1 CARTON SPRAY 1 2 51672-1390-8 Betamethasone dipropionate 1 in 1 CARTON SPRAY 1 2 51672-1390-8 Betamethasone dipropionate 120 g in 1 BOTTLE SPRAY 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1390 BETAMETHASONE DIPROPIONATE SPRAY [TARO PHARMACEUTICALS U.S.A., INC.] 1 Current NDC, Legacy NDC, 4 package rows 20200701_dc3dd2f7-38ad-4c4c-8602-29b33cc6af90.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 51672-1390-4 51672139004 1 BOTTLE in 1 CARTON (51672-1390-4) / 60 g in 1 BOTTLE 1 bottle 2020-06-17 0000-00-00 No No Current 51672-1390-8 51672139008 1 BOTTLE in 1 CARTON (51672-1390-8) / 120 g in 1 BOTTLE 1 bottle 2020-06-17 0000-00-00 No No Current