Home NDC 70954-301-20 Mesalamine
Product NDC 70954-301
Requested package NDC 70954-301-20
11-digit product format 709540301
Labeler code 70954
Product ID 70954-301_9411a710-a60c-4f4b-a28c-1f72d80eaf35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mesalamine
Dosage form SUSPENSION
Route RECTAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA215269
Marketing category ANDA
Marketing start 2026-05-14
Substance MESALAMINE
Active strength 4 g/60mL
Pharmacologic classes Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70954-301 70954-301-20 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70954-301 70954-301-20 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A215269-001 MESALAMINE MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2025-04-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215269-001 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 2026-02-19 14:30 UTC 2026-02 A215269-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2025-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215269-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2025-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215269-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2025-04-16 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215269-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2025-04-16 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A215269-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215269-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215269-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215269-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Mesalamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MESALAMINE 4 g/60mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Q81I59GXC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238151 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 70954-301-10 Mesalamine 60 mL in 1 BOTTLE SUSPENSION 60 3 70954-301-20 Mesalamine 7 in 1 CARTON SUSPENSION 7 3
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70954-301-20 70954030120 7 BOTTLE in 1 CARTON (70954-301-20) / 60 mL in 1 BOTTLE (70954-301-10) 7 bottle 2026-05-14 No No Current