FDA.reportPublic FDA data

Hydrocortisone Butyrate

Product NDC
0472-0490
11-digit product format
004720490
Labeler code
0472
Product ID
0472-0490_c3cbc815-c1ae-4e7c-8b4b-2ac3d5c3a005
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone Butyrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA205134
Marketing category
ANDA
Marketing start
2018-02-16
Marketing end
2019-08-31
Substance
HYDROCORTISONE BUTYRATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0472-0490DDiscontinued by firm2026-07-31
excluded packagepackage0472-04900472-0490-15DDiscontinued by firm2026-07-31
excluded packagepackage0472-04900472-0490-45DDiscontinued by firm2026-07-31
excluded packagepackage0472-04900472-0490-60DDiscontinued by firm2026-07-31

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
A205134-001HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATE0.1%CREAM / TOPICALAB22017-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A205134-001AB2

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 22:54:322026-06A205134-001HYDROCORTISONE BUTYRATE0.1%CREAM / TOPICALAB22017-12-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205134-001AB21a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0490-45GM - Gram0472-0490b81da5e9-3151-4749-b26c-38999912319b12018-03-08
0472-0490-60GM - Gram0472-0490f1026977-5199-4976-a66f-57787cdbb50112018-03-08