Home NDC 70710-1958 Indomethacin
Product NDC 70710-1958
11-digit product format 707101958
Labeler code 70710
Product ID 70710-1958_472b97d6-5eef-4fc5-8a01-b5466d00715e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form SUPPOSITORY
Route RECTAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA216184
Marketing category ANDA
Marketing start 2024-04-15
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 2026-12-31
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 A216184-001 INDOMETHACIN INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216184-001 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 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216184-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB 2023-08-02 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 A216184-001 CGT 2024-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216184-001 CGT 2024-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216184-001 CGT 2024-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216184-001 CGT 2024-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216184-001 CGT 2024-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216184-001 CGT 2024-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216184-001 CGT 2024-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216184-001 CGT 2024-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216184-001 CGT 2024-01-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216184-001 CGT 2024-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216184-001 CGT 2024-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216184-001 CGT 2024-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216184-001 CGT 2024-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216184-001 CGT 2024-01-30 9b2671bbb829…
Additional Listing Data#
Finished product Yes
Brand name base Indomethacin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDOMETHACIN 50 mg/1
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 197819 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 70710-1958-6 Indomethacin 6 in 1 BLISTER PACK SUPPOSITORY 6 3 70710-1958-7 Indomethacin 5 in 1 CARTON SUPPOSITORY 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1958 INDOMETHACIN SUPPOSITORY [ZYDUS PHARMACEUTICALS USA INC.] 3 Current NDC, 2 package rows 20241013_7c911ac4-db70-44bf-8374-01c8260aa3d4.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 · 3 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 70710-1958-6 70710195806 6 in 1 BLISTER PACK Historical 70710-1958-7 70710195807 5 BLISTER PACK in 1 CARTON (70710-1958-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1958-6) 5 blister pack 2024-04-15 No No Current