Home NDC 70954-637 Indomethacin
Product NDC 70954-637
11-digit product format 709540637
Labeler code 70954
Product ID 70954-637_a2bb8e18-c1c2-4f73-ac4d-139a21488902
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form SUSPENSION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA217883
Marketing category ANDA
Marketing start 2024-01-12
Substance INDOMETHACIN
Active strength 25 mg/5mL
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 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 A217883-001 INDOMETHACIN INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217883-001 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 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217883-001 INDOMETHACIN 25MG/5ML SUSPENSION / ORAL AB 2024-01-12 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217883-001 CGT 2024-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217883-001 CGT 2024-07-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217883-001 CGT 2024-07-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217883-001 CGT 2024-07-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217883-001 CGT 2024-07-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217883-001 CGT 2024-07-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217883-001 CGT 2024-07-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217883-001 CGT 2024-07-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217883-001 CGT 2024-07-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217883-001 CGT 2024-07-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217883-001 CGT 2024-07-10 1c564ffb4f44…
Additional Listing Data#
Finished product Yes
Brand name base Indomethacin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDOMETHACIN 25 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XXE1CET956 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310991 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 70954-637-10 Indomethacin 237 mL in 1 BOTTLE SUSPENSION 237 4 70954-637-10 Indomethacin 1 in 1 CARTON SUSPENSION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-637 INDOMETHACIN SUSPENSION [ANI PHARMACEUTICALS, INC.] 3 Current NDC, 2 package rows 20250410_e8b86758-6cb5-44ac-a5fc-2111e98a19a8.zip
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 70954-637-10 70954063710 1 BOTTLE in 1 CARTON (70954-637-10) / 237 mL in 1 BOTTLE 1 bottle 2024-01-12 No No Current