Home NDC 65162-360-18 Mesalamine
Product NDC 65162-360
Requested package NDC 65162-360-18
11-digit product format 651620360
Labeler code 65162
Product ID 65162-360_4923f79f-af2b-425a-9ec0-b5e56ed0fdb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mesalamine
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA215067
Marketing category ANDA
Marketing start 2025-02-19
Substance MESALAMINE
Active strength 800 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 45 .
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 A215067-001 MESALAMINE MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215067-001 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 2026-11-14 07:37:17 2026-10 A215067-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-18 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A215067-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 A215067-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215067-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215067-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215067-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215067-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215067-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-18 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215067-001 MESALAMINE 800MG TABLET, DELAYED RELEASE / ORAL AB 2025-02-18 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 800 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 833234 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 65162-360-18 Mesalamine 180 in 1 BOTTLE TABLET, DELAYED RELEASE 180 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-360 MESALAMINE TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC] 9 Current NDC, 1 package rows 20250221_00f77203-3615-47e8-ae25-6e1cf8a2a00a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 65162-360-18 65162036018 180 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-360-18) 2025-02-19 No No Current