FDA.reportPublic FDA data

Procto-Pak

Product NDC
64980-302
Requested package NDC
64980-302-30
11-digit product format
649800302
Labeler code
64980
Product ID
64980-302_384f2adf-43c5-410b-8a1e-d856ac3d8a17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA087795
Marketing category
ANDA
Marketing start
2012-06-01
Marketing end
0000-00-00
Substance
HYDROCORTISONE
Active strength
10 mg/g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64980-30264980-302-30DDiscontinued 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
A087795-001HYDROCORTISONEHYDROCORTISONE1%CREAM / TOPICALAT1983-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A087795-001AT

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 22:54:322026-06A087795-001HYDROCORTISONE1%CREAM / TOPICALAT1983-05-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A087795-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCORTISONEHYDROCORTISONEDIRECT RXc28c3ceb-1807-b43b-e053-2995a90a2aba2025-01-17Adverse reactionsExact identifier
application applno (ANDA): 087795
application number: ANDA087795
HydrocortisoneHYDROCORTISONEActavis Pharma, Inc.aa9dba84-eb38-4ec3-8555-87c948bf23842020-07-01Adverse reactionsExact identifier
application applno (ANDA): 087795
application number: ANDA087795

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64980-302-302024-03-12C16284748780-1d6a99b39-68dd-a426-e053-dadaa90af4c2HYDROCORTISONE CREAM, USP 1% HYDROCORTISONE OINTMENT, USP 1% TOPICAL CORTICOSTEROID Rx Only
64980-302-302022-01-28C16284748780-1d6a99b39-68dd-a426-e053-dadaa90af4c2HYDROCORTISONE CREAM, USP 1% HYDROCORTISONE OINTMENT, USP 1% TOPICAL CORTICOSTEROID Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-302-30GM - Gram64980-302b22acfda-29af-4efe-a9c4-7e5f02c27c0412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJPROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJPROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MPROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATPROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEPROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IPROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XPROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-302-30649800302301 TUBE in 1 CARTON (64980-302-30) > 28 g in 1 TUBE1 tube2012-06-010000-00-00NoNoCurrent