Home NDC 64980-302 Procto-Pak
Product NDC 64980-302
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.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 64980-302 D Discontinued by firm 2026-07-31 excluded package package 64980-302 64980-302-30 D Discontinued by firm 2026-07-31
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A087795-001 HYDROCORTISONE HYDROCORTISONE 1% CREAM / TOPICAL AT 1983-05-03
Therapeutic equivalence codes# Application-product, TE code table Application-product TE code A087795-001 AT
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.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria. To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 ISOPROPYL PALMITATE INACTIVE INGREDIENT 8CRQ2TH63M PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 PARAFFIN INACTIVE INGREDIENT I9O0E3H2ZE PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PROCTO-PAK (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-302-30 64980030230 1 TUBE in 1 CARTON (64980-302-30) > 28 g in 1 TUBE 1 tube 2012-06-01 0000-00-00 No No Current