Home NDC 43063-368 Indomethacin
Product NDC 43063-368
11-digit product format 430630368
Labeler code 43063
Product ID 43063-368_508ccad6-eddc-ccfa-e063-6394a90a17cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA091276
Marketing category ANDA
Marketing start 2010-12-22
Substance INDOMETHACIN
Active strength 25 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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091276-001 INDOMETHACIN INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 A091276-002 INDOMETHACIN INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091276-001 INDOMETHACIN 25MG CAPSULE / ORAL AB 2010-12-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091276-002 INDOMETHACIN 50MG CAPSULE / ORAL AB RS 2010-12-22 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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 25 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 197817 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 43063-368-06 Indomethacin 6 in 1 BOTTLE, PLASTIC CAPSULE 6 18 43063-368-15 Indomethacin 15 in 1 BOTTLE, PLASTIC CAPSULE 15 18 43063-368-30 Indomethacin 30 in 1 BOTTLE, PLASTIC CAPSULE 30 18 43063-368-90 Indomethacin 90 in 1 BOTTLE, PLASTIC CAPSULE 90 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-368 INDOMETHACIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] 16 Current NDC, Legacy NDC, 4 package rows 20240922_b4cf01d1-0d71-4f0f-97a5-07a59744149f.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 2 of 2 · 21 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 43063-368-06 43063036806 6 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-06) 6 capsule 2012-02-23 0000-00-00 No No Current 43063-368-15 43063036815 15 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-15) 15 capsule 2017-05-11 0000-00-00 No No Current 43063-368-30 43063036830 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-30) 30 capsule 2017-02-07 0000-00-00 No No Current 43063-368-90 43063036890 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-368-90) 90 capsule 2024-06-06 No No Current