FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
70030-166
11-digit product format
700300166
Labeler code
70030
Product ID
70030-166_e9f5fdfb-9638-4bdc-b078-3de17f4b270c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
HyGen Pharmaceuticals, Inc.
Application
ANDA074222
Marketing category
ANDA
Marketing start
2018-03-23
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
0 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70030-166IInactivated by FDA2026-07-31
excluded packagepackage70030-16670030-166-25IInactivated by FDA2026-07-31
excluded packagepackage70030-16670030-166-50IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074222-001EMBELINECLOBETASOL PROPIONATE0.05%SOLUTION / TOPICAL1995-12-06

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074222-001EMBELINE0.05%SOLUTION / TOPICAL1995-12-06a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70030-166-252021-01-29C16284748780-1ba0f9c33-2348-a910-e053-dadaa90a0b85Clobetasol Propionate Topical Solution, USP, 0.05%
70030-166-502021-01-29C16284748780-1ba0f9c33-2348-a910-e053-dadaa90a0b85Clobetasol Propionate Topical Solution, USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70030-166-25Clobetasol Propionate1 in 1 CARTONSOLUTION11
70030-166-25Clobetasol Propionate25 mL in 1 BOTTLESOLUTION251
70030-166-50Clobetasol Propionate1 in 1 CARTONSOLUTION11
70030-166-50Clobetasol Propionate50 mL in 1 BOTTLESOLUTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70030-166CLOBETASOL PROPIONATE SOLUTION [HYGEN PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20180324_86126839-2dee-45fd-9bf0-29578538743a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70030-166-25700300166251 in 1 CARTONHistorical
70030-166-50700300166501 in 1 CARTONHistorical