Home NDC 62135-020-21 Hydrocortisone Rectal Suspension (Retention)
Product NDC 62135-020
Requested package NDC 62135-020-21
11-digit product format 621350020
Labeler code 62135
Product ID 62135-020_459c2035-71cd-e07e-e063-6394a90a5a3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone
Dosage form SUSPENSION
Route RECTAL
Labeler Chartwell RX LLC
Application ANDA075172
Marketing category ANDA
Marketing start 1999-12-03
Substance HYDROCORTISONE
Active strength 100 mg/60mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075172-001 COLOCORT HYDROCORTISONE 100MG/60ML ENEMA / RECTAL AB 1999-12-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075172-001 AB
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 A075172-001 COLOCORT 100MG/60ML ENEMA / RECTAL AB 1999-12-03 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 A075172-001 AB 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.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone Rectal Suspension (Retention)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 100 mg/60mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310878 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 62135-020-07 Hydrocortisone Rectal Suspension (Retention) 60 mL in 1 BOTTLE SUSPENSION 60 6 62135-020-07 Hydrocortisone Rectal Suspension (Retention) 7 in 1 CARTON SUSPENSION 7 6 62135-020-21 Hydrocortisone Rectal Suspension (Retention) 3 in 1 BOX SUSPENSION 3 6 62135-020-21 Hydrocortisone Rectal Suspension (Retention) 7 in 1 CARTON SUSPENSION 7 6 62135-020-46 Hydrocortisone Rectal Suspension (Retention) 60 mL in 1 BOTTLE SUSPENSION 60 6 62135-020-46 Hydrocortisone Rectal Suspension (Retention) 1 in 1 CARTON SUSPENSION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-020 HYDROCORTISONE RECTAL SUSPENSION (RETENTION) (HYDROCORTISONE) SUSPENSION [CHARTWELL RX LLC] 5 Current NDC, Legacy NDC, 6 package rows 20241030_3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8.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 62135-020-21 62135002021 3 CARTON in 1 BOX (62135-020-21) / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE 3 carton 2021-11-18 0000-00-00 No No Current