Home NDC 68071-1581 Hydrocortisone
Product NDC 68071-1581
11-digit product format 680711581
Labeler code 68071
Product ID 68071-1581_bb12089e-cb65-6345-e053-2a95a90a8a2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone
Dosage form OINTMENT
Route TOPICAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA081203
Marketing category ANDA
Marketing start 1993-05-28
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 2022-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A081203-001 HYDROCORTISONE HYDROCORTISONE 2.5% OINTMENT / TOPICAL AT RS 1993-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A081203-001 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A081203-001 HYDROCORTISONE 2.5% OINTMENT / TOPICAL AT RS 1993-05-28 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A081203-001 AT 1 a50c72e98297…
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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 68071-1581-3 2024-07-17 C162847 48780-1 ba0f9c33-112b-a910-e053-dadaa90a0b85 HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5% 68071-1581-3 2023-01-30 C162847 48780-1 ba0f9c33-112b-a910-e053-dadaa90a0b85 HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5% 68071-1581-3 2021-02-11 C162847 48780-1 ba0f9c33-112b-a910-e053-dadaa90a0b85 HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5% 68071-1581-3 2021-01-29 C162847 48780-1 ba0f9c33-112b-a910-e053-dadaa90a0b85 HYDROCORTISONE CREAM USP, 2.5% HYDROCORTISONE OINTMENT USP, 2.5%
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-1581-3 68071158103 29 g in 1 BOX (68071-1581-3) 29 g 2017-09-14 0000-00-00 No No Current