Home NDC 0781-2791 Mesalamine
Product NDC 0781-2791
11-digit product format 007812791
Labeler code 0781
Product ID 0781-2791_52d8e30f-56bb-4822-8c6b-448ca3cd1923
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mesalamine
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Sandoz Inc
Application ANDA219997
Marketing category ANDA
Marketing start 2026-07-21
Substance MESALAMINE
Active strength 250 mg/1
Pharmacologic classes Aminosalicylate [EPC], Aminosalicylic Acids [CS]
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219997-001 MESALAMINE MESALAMINE 250MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 A219997-002 MESALAMINE MESALAMINE 500MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-09-14 22:38:34 2026-08 A219997-001 MESALAMINE 250MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219997-002 MESALAMINE 500MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219997-001 MESALAMINE 250MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219997-002 MESALAMINE 500MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219997-001 MESALAMINE 250MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219997-002 MESALAMINE 500MG CAPSULE, EXTENDED RELEASE / ORAL AB 2026-03-10 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mesalamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MESALAMINE 250 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314092 Internal RxNorm lookup 476362 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0781-2791-64 00781279164 240 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2791-64) 2026-07-21 No No Current