Home NDC 0178-0455 Texacort
Product NDC 0178-0455
11-digit product format 001780455
Labeler code 0178
Product ID 0178-0455_47e75db6-40d5-7014-e063-6294a90afcfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone
Dosage form SOLUTION
Route TOPICAL
Labeler Mission Pharmacal Company
Application ANDA081271
Marketing category ANDA
Marketing start 2011-12-15
Substance HYDROCORTISONE
Active strength 25 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A081271-001 TEXACORT HYDROCORTISONE 2.5% SOLUTION / TOPICAL RS 1992-04-17
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 A081271-001 TEXACORT 2.5% SOLUTION / TOPICAL RS 1992-04-17 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.
Additional Listing Data#
Finished product Yes
Brand name base Texacort
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 25 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197786 Internal RxNorm lookup 206336 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 0178-0455-01 Texacort 1 in 1 CARTON SOLUTION 1 6 0178-0455-01 Texacort 30 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION 30 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0178-0455 TEXACORT (HYDROCORTISONE) SOLUTION [MISSION PHARMACAL COMPANY] 5 Current NDC, Legacy NDC, 2 package rows 20240110_25279d46-6bad-471f-8bd6-736d53cfd942.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0178-0455-01 00178045501 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0178-0455-01) / 30 mL in 1 BOTTLE, WITH APPLICATOR 2011-12-15 0000-00-00 No No Current