Home NDC 0009-0044 CORTEF
Product NDC 0009-0044
11-digit product format 000090044
Labeler code 0009
Product ID 0009-0044_17306ca2-c631-4281-824c-1cb6d63dcac1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone
Dosage form TABLET
Route ORAL
Labeler Pharmacia & Upjohn Company LLC
Application NDA008697
Marketing category NDA
Marketing start 1952-12-15
Substance HYDROCORTISONE
Active strength 20 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N008697-001 CORTEF HYDROCORTISONE 10MG TABLET / ORAL AB RLD, Approved before 1982 N008697-002 CORTEF HYDROCORTISONE 20MG TABLET / ORAL AB RLD, RS, Approved before 1982 N008697-003 CORTEF HYDROCORTISONE 5MG TABLET / ORAL AB RLD, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 N008697-001 CORTEF 10MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N008697-002 CORTEF 20MG TABLET / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N008697-003 CORTEF 5MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base CORTEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197782 Internal RxNorm lookup 197783 Internal RxNorm lookup 197787 Internal RxNorm lookup 208680 Internal RxNorm lookup 208712 Internal RxNorm lookup 208816 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0009-0044-01 CORTEF 100 in 1 BOTTLE TABLET 100 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-0044 CORTEF (HYDROCORTISONE) TABLET [PHARMACIA & UPJOHN COMPANY LLC] 17 Current NDC, Legacy NDC, 1 package rows 20250221_9ce19944-dd88-4a7b-84ca-b07f4ec23bad.zip
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 0009-0044-01 00009004401 100 TABLET in 1 BOTTLE (0009-0044-01) 100 tablet 1952-12-15 0000-00-00 No No Current