Home NDC 0168-0041 Betamethasone Valerate
Product NDC 0168-0041
11-digit product format 001680041
Labeler code 0168
Product ID 0168-0041_41e96a74-4120-436e-97e5-2dc62af84b2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name betamethasone valerate
Dosage form LOTION
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application NDA018866
Marketing category NDA
Marketing start 1983-08-31
Substance BETAMETHASONE VALERATE
Active strength 1 mg/mL
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 N018866-001 BETAMETHASONE VALERATE BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / 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 N018866-001 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 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / TOPICAL AB RLD, RS 1983-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018866-001 BETAMETHASONE VALERATE EQ 0.1% BASE LOTION / 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/mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197407 Internal RxNorm lookup 197408 Internal RxNorm lookup 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 0168-0041-60 Betamethasone Valerate 60 mL in 1 BOTTLE LOTION 60 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BETAMETHASONE VALERATE ACTIVE INGREDIENT 9IFA5XM7R2 BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 BETAMETHASONE ACTIVE MOIETY 9842X06Q6M BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) INACTIVE INGREDIENT Z135WT9208 BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 CETETH-20 INACTIVE INGREDIENT I835H2IHHX BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 CHLOROCRESOL INACTIVE INGREDIENT 36W53O7109 BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 5 BETAMETHASONE VALERATE ACTIVE INGREDIENT 9IFA5XM7R2 BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 BETAMETHASONE VALERATE ACTIVE MOIETY 9IFA5XM7R2 BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 CETETH-20 INACTIVE INGREDIENT I835H2IHHX BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 CHLOROCRESOL INACTIVE INGREDIENT 36W53O7109 BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0041 BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 1 package rows 20220112_0b386ccc-a2d4-4d18-a2d7-e46ff894c674.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 0168-0041-60 00168004160 60 mL in 1 BOTTLE (0168-0041-60) 60 ml 1983-08-31 0000-00-00 No No Current