Home NDC 64980-301 Proctozone
Product NDC 64980-301
11-digit product format 649800301
Labeler code 64980
Product ID 64980-301_0c61d2ad-0795-455a-a720-a81df1a0b0e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Rising Pharmaceuticals, Inc.
Application ANDA089682
Marketing category ANDA
Marketing start 2012-05-01
Marketing end 0000-00-00
Substance HYDROCORTISONE
Active strength 25 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 64980-301 D Discontinued by firm 2026-07-31 excluded package package 64980-301 64980-301-30 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 A089682-001 HYDROCORTISONE HYDROCORTISONE 2.5% CREAM / TOPICAL 1988-03-10
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 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 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 and miliaria. To report SUSPECTED ADVERSE EVENTS, contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F PROCTOZONE HC (HYDROCORTISONE) CREAM [RISING PHARMACEUTICALS, INC.] 1 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F PROCTOZONE HC (HYDROCORTISONE) CREAM [PHYSICIANS TOTAL CARE, INC.] 1
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 64980-301-30 64980030130 1 TUBE in 1 CARTON (64980-301-30) > 30 g in 1 TUBE 1 tube 2012-05-01 0000-00-00 No No Current