Home NDC 84725-002-04 MESALAMINE
Product NDC 84725-002
Requested package NDC 84725-002-04
11-digit product format 847250002
Labeler code 84725
Product ID 84725-002_219908d6-9f7b-4fb0-8f14-009b1d783c9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mesalamine
Dosage form SUSPENSION
Route RECTAL
Labeler KLM Laboratories Private Limited
Application ANDA220016
Marketing category ANDA
Marketing start 2026-09-01
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A220016-001 MESALAMINE MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2026-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220016-001 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 2026-10-15 13:18:30 2026-09 A220016-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2026-03-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A220016-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2026-03-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220016-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2026-03-31 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220016-001 MESALAMINE 4GM/60ML ENEMA / RECTAL AB 2026-03-31 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 4 g/60mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84725-002-03 MESALAMINE 7 in 1 CARTON SUSPENSION 7 5 84725-002-03 MESALAMINE 60 mL in 1 BOTTLE SUSPENSION 60 5
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84725-002-04 84725000204 7 BOTTLE in 1 CARTON (84725-002-04) / 60 mL in 1 BOTTLE 7 bottle 2026-09-01 No No Current