Home NDC 68788-8496 Betamethasone Valerate
Product NDC 68788-8496
11-digit product format 687888496
Labeler code 68788
Product ID 68788-8496_5c93414e-0b79-4ecd-8760-7fa75c238edb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name betamethasone valerate
Dosage form OINTMENT
Route TOPICAL
Labeler Preferred Pharmaceuticals Inc.
Application NDA018865
Marketing category NDA
Marketing start 2023-07-26
Substance BETAMETHASONE VALERATE
Active strength 1 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 N018865-001 BETAMETHASONE VALERATE BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018865-001 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 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018865-001 BETAMETHASONE VALERATE EQ 0.1% BASE OINTMENT / TOPICAL AB RLD, RS 1983-08-31 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 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 197409 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 68788-8496-1 Betamethasone Valerate 15 g in 1 TUBE OINTMENT 15 5 68788-8496-4 Betamethasone Valerate 45 g in 1 TUBE OINTMENT 45 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8496 BETAMETHASONE VALERATE OINTMENT [PREFERRED PHARMACEUTICALS INC.] 4 Current NDC, 2 package rows 20250210_50d4763d-5a84-4c45-be06-040c4a527470.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8496-1 68788849601 15 g in 1 TUBE (68788-8496-1) 15 g 2023-07-26 No No Current 68788-8496-4 68788849604 45 g in 1 TUBE (68788-8496-4) 45 g 2023-07-26 No No Current