Home NDC 45802-053 Betamethasone Valerate
Product NDC 45802-053
11-digit product format 458020053
Labeler code 45802
Product ID 45802-053_af10e709-e348-420b-aa9b-154c15cc5df3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Betamethasone Valerate
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA078337
Marketing category ANDA
Marketing start 2013-01-15
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 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 A078337-001 BETAMETHASONE VALERATE BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078337-001 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 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078337-001 BETAMETHASONE VALERATE 0.12% AEROSOL, FOAM / TOPICAL AB 2012-11-26 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 1.2 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 45802-053-01 Betamethasone Valerate 1 in 1 CARTON AEROSOL, FOAM 1 10 45802-053-01 Betamethasone Valerate 50 g in 1 CAN AEROSOL, FOAM 50 10 45802-053-02 Betamethasone Valerate 1 in 1 CARTON AEROSOL, FOAM 1 10 45802-053-02 Betamethasone Valerate 100 g in 1 CAN AEROSOL, FOAM 100 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BETAMETHASONE VALERATE ACTIVE INGREDIENT 9IFA5XM7R2 BETAMETHASONE VALERATE AEROSOL, FOAM [PERRIGO NEW YORK INC] 5 BETAMETHASONE ACTIVE MOIETY 9842X06Q6M BETAMETHASONE VALERATE AEROSOL, FOAM [PERRIGO NEW YORK INC] 5 ALCOHOL INACTIVE INGREDIENT 3K9958V90M BETAMETHASONE VALERATE AEROSOL, FOAM [PERRIGO NEW YORK INC] 5 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN BETAMETHASONE VALERATE AEROSOL, FOAM [PERRIGO NEW YORK INC] 5 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BETAMETHASONE VALERATE AEROSOL, FOAM [PERRIGO NEW YORK INC] 5 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M BETAMETHASONE VALERATE AEROSOL, FOAM [PERRIGO NEW YORK INC] 5 POTASSIUM CITRATE INACTIVE INGREDIENT EE90ONI6FF BETAMETHASONE VALERATE AEROSOL, FOAM [PERRIGO NEW YORK INC] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BETAMETHASONE VALERATE AEROSOL, FOAM [PERRIGO NEW YORK INC] 5 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y BETAMETHASONE VALERATE AEROSOL, FOAM [PERRIGO NEW YORK INC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R BETAMETHASONE VALERATE AEROSOL, FOAM [PERRIGO NEW YORK INC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-053 BETAMETHASONE VALERATE AEROSOL, FOAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] 10 Current NDC, Legacy NDC, 4 package rows 20241222_dc5dfd3e-7762-40c8-880e-c7db80d87749.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 45802-053-01 45802005301 1 CAN in 1 CARTON (45802-053-01) / 50 g in 1 CAN 1 can 2013-01-15 0000-00-00 No No Current 45802-053-02 45802005302 1 CAN in 1 CARTON (45802-053-02) / 100 g in 1 CAN 1 can 2013-01-15 0000-00-00 No No Current