Home NDC 69344-102 INDOCIN
Product NDC 69344-102
11-digit product format 693440102
Labeler code 69344
Product ID 69344-102_462a8532-9cea-682f-e063-6394a90a50e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form SUPPOSITORY
Route RECTAL
Labeler Zyla Life Sciences US Inc.
Application ANDA073314
Marketing category ANDA
Marketing start 1992-08-31
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 42 .
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 A073314-001 INDOMETHACIN INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073314-001 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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL AB RS 1992-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base INDOCIN
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197819 Internal RxNorm lookup 206969 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 69344-102-33 INDOCIN 30 in 1 BOX SUPPOSITORY 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69344-102 INDOCIN (INDOMETHACIN) SUPPOSITORY [ZYLA LIFE SCIENCES US LLC] 5 Current NDC, Legacy NDC, 1 package rows 20230729_3b36645c-de5e-4263-ae06-2f6ff6a9add2.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INDOCIN INDOMETHACIN Zyla Life Sciences US Inc. 3b36645c-de5e-4263-ae06-2f6ff6a9add2 2025-12-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073314 application number: ANDA073314 ndc (product): 69344-102
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 69344-102-33 69344010233 30 SUPPOSITORY in 1 BOX (69344-102-33) 30 suppository 1992-08-31 0000-00-00 No No Current