Home NDC 10702-016 INDOMETHACIN
Product NDC 10702-016
11-digit product format 107020016
Labeler code 10702
Product ID 10702-016_30a4fdec-3f89-034c-e063-6294a90aa786
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Indomethacin
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler KVK-Tech, Inc.
Application ANDA079175
Marketing category ANDA
Marketing start 2009-03-06
Substance INDOMETHACIN
Active strength 75 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 A079175-001 INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE / ORAL AB 2009-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079175-001 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 2026-08-01 22:54:32 2026-06 A079175-001 INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE / ORAL AB 2009-03-06 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A079175-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INDOMETHACIN INDOMETHACIN Bryant Ranch Prepack 41af7776-36bc-4820-b635-e7c69f26997e 2026-03-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079175 application number: ANDA079175 Indomethacin INDOMETHACIN American Health Packaging 5a65b650-ea9b-4d0d-b62f-5971df1e62b4 2025-10-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 079175 application number: ANDA079175 INDOMETHACIN INDOMETHACIN PD-Rx Pharmaceuticals, Inc. 85014b51-1354-4d16-9995-3ee33a7155fa 2025-05-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079175 application number: ANDA079175 INDOMETHACIN INDOMETHACIN KVK-Tech, Inc. dc80228c-acae-44dc-9762-19bd1669bf45 2025-03-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 079175 application number: ANDA079175 ndc (product): 10702-016
Additional Listing Data#
Finished product Yes
Brand name base INDOMETHACIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDOMETHACIN 75 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 310992 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10702-016-01 INDOMETHACIN 100 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 100 15 10702-016-03 INDOMETHACIN 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 15 10702-016-06 INDOMETHACIN 60 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 60 15 10702-016-09 INDOMETHACIN 90 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 90 15 10702-016-10 INDOMETHACIN 1000 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 1000 15 10702-016-50 INDOMETHACIN 500 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 500 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] 3 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDOMETHACIN CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] 3 INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] 2 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 ETHYLCELLULOSE INACTIVE INGREDIENT 7Z8S9VYZ4B INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 SODIUM LAURETH SULFATE INACTIVE INGREDIENT BPV390UAP0 INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDOMETHACIN CAPSULE, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDOMETHACIN ER (INDOMETHACIN) CAPSULE [APOTHECA, INC.] 2 INDOMETHACIN ACTIVE INGREDIENT XXE1CET956 INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 1 INDOMETHACIN ACTIVE MOIETY XXE1CET956 INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10702-016 INDOMETHACIN CAPSULE, EXTENDED RELEASE [KVK-TECH, INC.] 15 Current NDC, Legacy NDC, 6 package rows 20250322_dc80228c-acae-44dc-9762-19bd1669bf45.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 10702-016-01 10702001601 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-01) 2009-03-06 0000-00-00 No No Current 10702-016-03 10702001603 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-03) 2011-02-02 0000-00-00 No No Current 10702-016-06 10702001606 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-06) 2009-03-06 0000-00-00 No No Current 10702-016-09 10702001609 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-09) 2011-02-02 0000-00-00 No No Current 10702-016-10 10702001610 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-10) 2009-03-06 0000-00-00 No No Current 10702-016-50 10702001650 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-50) 2009-03-06 0000-00-00 No No Current