Home NDC 0713-0176 INDOMETHACIN
Product NDC 0713-0176
11-digit product format 007130176
Labeler code 0713
Product ID 0713-0176_446ff6fb-cc69-4dd6-8cbe-12dfb5539ed7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name INDOMETHACIN
Dosage form SUPPOSITORY
Route RECTAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA073314
Marketing category ANDA
Marketing start 1992-08-31
Marketing end 0000-00-00
Substance INDOMETHACIN
Active strength 50 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0713-0176-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0713-0176-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0713-0176-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0713-0176-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0713-0176-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0713-0176-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0713-0176-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0713-0176-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0713-0176-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0713-0176-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0713-0176-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0713-0176-30 557ba5c1ecfa…9c80585c8c6e…
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 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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A073314-001 INDOMETHACIN 50MG SUPPOSITORY / RECTAL RS 1992-08-31 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Indomethacin ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN (INDOMETHACIN) SUPPOSITORY [G & W LABORATORIES, INC.] 1 Indomethacin ACTIVE MOIETY XXE1CET956 INDOMETHACIN (INDOMETHACIN) SUPPOSITORY [G & W LABORATORIES, INC.] 1 Butylated Hydroxyanisole INACTIVE INGREDIENT REK4960K2U INDOMETHACIN (INDOMETHACIN) SUPPOSITORY [G & W LABORATORIES, INC.] 1 Butylated Hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K INDOMETHACIN (INDOMETHACIN) SUPPOSITORY [G & W LABORATORIES, INC.] 1 Edetic Acid INACTIVE INGREDIENT 9G34HU7RV0 INDOMETHACIN (INDOMETHACIN) SUPPOSITORY [G & W LABORATORIES, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX INDOMETHACIN (INDOMETHACIN) SUPPOSITORY [G & W LABORATORIES, INC.] 1 Polyethylene Glycol 3350 INACTIVE INGREDIENT G2M7P15E5P INDOMETHACIN (INDOMETHACIN) SUPPOSITORY [G & W LABORATORIES, INC.] 1 Polyethylene Glycol 8000 INACTIVE INGREDIENT Q662QK8M3B INDOMETHACIN (INDOMETHACIN) SUPPOSITORY [G & W LABORATORIES, INC.] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X INDOMETHACIN (INDOMETHACIN) SUPPOSITORY [G & W LABORATORIES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R INDOMETHACIN (INDOMETHACIN) SUPPOSITORY [G & W LABORATORIES, INC.] 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 · 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0713-0176-30 00713017630 30 SUPPOSITORY in 1 BOX (0713-0176-30) 30 suppository 1992-08-31 0000-00-00 No No Current