Home NDC 72603-281 Indomethacin
Product NDC 72603-281
11-digit product format 726030281
Labeler code 72603
Product ID 72603-281_5e7c8e30-b627-0cc6-e063-6294a90a9d4a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form SUPPOSITORY
Route RECTAL
Labeler NorthStar RxLLC
Application ANDA216905
Marketing category ANDA
Marketing start 2025-12-20
Substance INDOMETHACIN
Active strength 50 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 A216905-001 INDOMETHACIN INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2025-07-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216905-001 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 A216905-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2025-07-03 c2088c7a36db…2026-09-14 22:38:34 2026-08 A216905-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2025-07-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216905-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2025-07-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216905-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2025-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216905-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2025-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216905-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2025-07-03 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216905-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2025-07-03 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 Indomethacin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDOMETHACIN 50 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72603-281-01 Indomethacin 6 in 1 BLISTER PACK SUPPOSITORY 6 1 72603-281-30 Indomethacin 30 in 1 CARTON SUPPOSITORY 30 1
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 · 2 matching rows.
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 72603-281-01 72603028101 6 in 1 BLISTER PACK Historical 72603-281-30 72603028130 30 BLISTER PACK in 1 CARTON (72603-281-30) / 6 SUPPOSITORY in 1 BLISTER PACK (72603-281-01) 30 blister pack 2025-12-20 2027-11-30 No No Historical