Indomethacin

Product NDC: 31722-543
11-digit product format: 317220543
Labeler code: 31722
Product ID: 31722-543_349de484-29cd-3e15-e063-6394a90a5aa5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Indomethacin
Dosage form: CAPSULE
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA091240
Marketing category: ANDA
Marketing start: 2016-05-19
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091240-001	INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE / ORAL	AB		2011-04-12
A091240-002	INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE / ORAL	AB		2011-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091240-001	AB
A091240-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091240-001	INDOMETHACIN	25MG	CAPSULE / ORAL	AB	2011-04-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091240-002	INDOMETHACIN	50MG	CAPSULE / ORAL	AB	2011-04-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091240-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091240-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091240-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091240-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091240-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091240-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091240-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091240-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091240-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091240-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091240-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091240-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091240-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091240-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091240-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091240-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091240-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091240-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091240-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091240-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091240-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091240-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091240-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091240-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091240-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091240-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091240-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091240-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091240-002	AB	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197817	Internal RxNorm lookup
197818	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1ce9c3c5-0cf7-4760-988d-2559adcfb200	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
234b5275-84d6-d169-e08f-554a8aed3f0a	Product name	3	20250717
9aaf7cf4-60c3-b44f-e302-fd8b276c713b	Product name	2	20250107
c6b2f0e9-1a13-02e4-f789-55c724469f07	Product name	7	20171115
6e9718b9-62b9-458f-9408-30d688800922	Product name	1	20171103
d62774ab-b1b9-2d5c-924f-1948e411ae15	Product name	3	20170816
97c70338-ee37-4c78-a047-53ee1cd9b53d	Product name	1	20150616

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-543-01	Indomethacin	100 in 1 BOTTLE	CAPSULE	100	8
31722-543-01	Indomethacin	12 in 1 CASE	CAPSULE	12	8
31722-543-05	Indomethacin	500 in 1 BOTTLE	CAPSULE	500	8
31722-543-05	Indomethacin	12 in 1 CASE	CAPSULE	12	8
31722-543-10	Indomethacin	1000 in 1 BOTTLE	CAPSULE	1000	8
31722-543-10	Indomethacin	12 in 1 CASE	CAPSULE	12	8
31722-543-30	Indomethacin	12 in 1 CASE	CAPSULE	12	8
31722-543-30	Indomethacin	30 in 1 BOTTLE	CAPSULE	30	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-543-01	EA - Each	31722-543	b6a75293-7242-4cc8-9e78-fb0a6a4485ad	1	2012-07-24
31722-543-05	EA - Each	31722-543	68f09d09-2e9f-4fda-88cd-37092edf77fe	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [DIRECT RX]	3
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [DIRECT RX]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [DIRECT RX]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [DIRECT RX]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [DIRECT RX]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [DIRECT RX]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [DIRECT RX]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [DIRECT RX]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [DIRECT RX]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [DIRECT RX]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INDOMETHACIN CAPSULE [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [DIRECT RX]	3
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [PROFICIENT RX LP]	2
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [AVPAK]	1
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
INDOMETHACIN	ACTIVE INGREDIENT	XXE1CET956	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [AVPAK]	1
INDOMETHACIN	ACTIVE MOIETY	XXE1CET956	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [AVPAK]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [AVPAK]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [AVPAK]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [AVPAK]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INDOMETHACIN CAPSULE [AVPAK]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [AVPAK]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [AVPAK]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	INDOMETHACIN CAPSULE [AVPAK]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INDOMETHACIN CAPSULE [AVPAK]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [AVPAK]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INDOMETHACIN CAPSULE [CAMBER PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-543	INDOMETHACIN (INDOMETHACIN) CAPSULE [CAMBER PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 8 package rows	20250509_1ce9c3c5-0cf7-4760-988d-2559adcfb200.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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Indomethacin	INDOMETHACIN	A-S Medication Solutions	d2997707-1541-4f5d-8c8d-70b0a13be8b2	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	St. Mary's Medical Park Pharmacy	205fc4e7-e118-509e-e063-6394a90a78e6	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	ce866d3a-7bea-4d82-9b7d-79e8a294c141	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	PD-Rx Pharmaceuticals, Inc.	d66ada00-3ece-4b71-8c59-a0db48a2db80	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals, Inc.	3785c914-0037-49ef-b6f5-a5e868ae490b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
INDOMETHACIN	INDOMETHACIN	DIRECT RX	7e7175d7-5e43-4151-9702-88ac2cd44ef6	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Northwind Health Company, LLC	dffe9b95-3cb6-4c4e-e053-2a95a90a9328	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Preferred Pharmaceuticals Inc.	971c4d53-7876-4f42-ba2d-c391714fa341	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	A-S Medication Solutions	5b05b8bc-4df0-4175-bf53-72129fb21b50	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	a329976b-4a01-42ea-a666-0ac99ed2522e	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Camber Pharmaceuticals, Inc.	1ce9c3c5-0cf7-4760-988d-2559adcfb200	2025-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240 ndc (product): 31722-543
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff7	2025-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	67b16cf2-e24c-4fe3-8d74-e63549b7659f	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	b1bb9349-21e4-4e6a-9916-3aac6c4d01b8	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	3fd56b7d-2799-4211-9a58-c6c1dc8c70dc	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	2f4a5796-5317-4caa-83e4-0595fe844df4	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	AvPAK	bcaa0e51-a2fc-cf74-027a-1964e38c5e4e	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	9236d783-d7b8-4486-94c6-5ecd876bc475	2024-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	56e19868-3973-4f1b-b80f-1f7daf1f1c22	2024-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240
Indomethacin	INDOMETHACIN	Bryant Ranch Prepack	afbb24fd-3695-4a30-a8a6-36239e35a14f	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091240 application number: ANDA091240

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XXE1CET956	INDOMETHACIN	53-86-1	INDOMETHACIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197818	indomethacin 50 MG Oral Capsule	PSN	afbb24fd-3695-4a30-a8a6-36239e35a14f	106
197818	indomethacin 50 MG Oral Capsule	SCD	afbb24fd-3695-4a30-a8a6-36239e35a14f	106
197818	indomethacin 50 MG Oral Capsule	PSN	3fd56b7d-2799-4211-9a58-c6c1dc8c70dc	102
197818	indomethacin 50 MG Oral Capsule	SCD	3fd56b7d-2799-4211-9a58-c6c1dc8c70dc	102
197818	indomethacin 50 MG Oral Capsule	PSN	4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff7	101
197818	indomethacin 50 MG Oral Capsule	SCD	4cc7ef3b-fddd-49dd-85d1-cbb3d5c17ff7	101
197817	indomethacin 25 MG Oral Capsule	PSN	d2997707-1541-4f5d-8c8d-70b0a13be8b2	33
197818	indomethacin 50 MG Oral Capsule	PSN	d2997707-1541-4f5d-8c8d-70b0a13be8b2	33
197817	indomethacin 25 MG Oral Capsule	SCD	d2997707-1541-4f5d-8c8d-70b0a13be8b2	33
197818	indomethacin 50 MG Oral Capsule	SCD	d2997707-1541-4f5d-8c8d-70b0a13be8b2	33
197817	indomethacin 25 MG Oral Capsule	PSN	5b05b8bc-4df0-4175-bf53-72129fb21b50	22
197818	indomethacin 50 MG Oral Capsule	PSN	5b05b8bc-4df0-4175-bf53-72129fb21b50	22
197817	indomethacin 25 MG Oral Capsule	SCD	5b05b8bc-4df0-4175-bf53-72129fb21b50	22
197818	indomethacin 50 MG Oral Capsule	SCD	5b05b8bc-4df0-4175-bf53-72129fb21b50	22
197818	indomethacin 50 MG Oral Capsule	PSN	d66ada00-3ece-4b71-8c59-a0db48a2db80	15
197818	indomethacin 50 MG Oral Capsule	SCD	d66ada00-3ece-4b71-8c59-a0db48a2db80	15
197818	indomethacin 50 MG Oral Capsule	PSN	a329976b-4a01-42ea-a666-0ac99ed2522e	9
197818	indomethacin 50 MG Oral Capsule	SCD	a329976b-4a01-42ea-a666-0ac99ed2522e	9
197817	indomethacin 25 MG Oral Capsule	PSN	1ce9c3c5-0cf7-4760-988d-2559adcfb200	8
197818	indomethacin 50 MG Oral Capsule	PSN	1ce9c3c5-0cf7-4760-988d-2559adcfb200	8
197817	indomethacin 25 MG Oral Capsule	SCD	1ce9c3c5-0cf7-4760-988d-2559adcfb200	8
197818	indomethacin 50 MG Oral Capsule	SCD	1ce9c3c5-0cf7-4760-988d-2559adcfb200	8
197817	indomethacin 25 MG Oral Capsule	PSN	bcaa0e51-a2fc-cf74-027a-1964e38c5e4e	7
197818	indomethacin 50 MG Oral Capsule	PSN	7e7175d7-5e43-4151-9702-88ac2cd44ef6	7
197818	indomethacin 50 MG Oral Capsule	PSN	bcaa0e51-a2fc-cf74-027a-1964e38c5e4e	7
197817	indomethacin 25 MG Oral Capsule	SCD	bcaa0e51-a2fc-cf74-027a-1964e38c5e4e	7
197818	indomethacin 50 MG Oral Capsule	SCD	7e7175d7-5e43-4151-9702-88ac2cd44ef6	7
197818	indomethacin 50 MG Oral Capsule	SCD	bcaa0e51-a2fc-cf74-027a-1964e38c5e4e	7
197818	indomethacin 50 MG Oral Capsule	PSN	66e3205b-eab1-4864-bf36-116e9d79fe3e	6
197818	indomethacin 50 MG Oral Capsule	SCD	66e3205b-eab1-4864-bf36-116e9d79fe3e	6
197818	indomethacin 50 MG Oral Capsule	PSN	3e87e34a-6556-4b0f-e054-00144ff8d46c	5
197818	indomethacin 50 MG Oral Capsule	SCD	3e87e34a-6556-4b0f-e054-00144ff8d46c	5
197817	indomethacin 25 MG Oral Capsule	PSN	67b16cf2-e24c-4fe3-8d74-e63549b7659f	4
197818	indomethacin 50 MG Oral Capsule	PSN	505a18fd-5072-4c66-9ee9-d654fc2b4e61	4
197818	indomethacin 50 MG Oral Capsule	PSN	67b16cf2-e24c-4fe3-8d74-e63549b7659f	4
197817	indomethacin 25 MG Oral Capsule	SCD	67b16cf2-e24c-4fe3-8d74-e63549b7659f	4
197818	indomethacin 50 MG Oral Capsule	SCD	67b16cf2-e24c-4fe3-8d74-e63549b7659f	4
197818	indomethacin 50 MG Oral Capsule	SCD	505a18fd-5072-4c66-9ee9-d654fc2b4e61	4
197818	indomethacin 50 MG Oral Capsule	PSN	205fc4e7-e118-509e-e063-6394a90a78e6	3
197818	indomethacin 50 MG Oral Capsule	PSN	891ab059-a11e-0f81-e053-2995a90a03bf	3
197818	indomethacin 50 MG Oral Capsule	SCD	891ab059-a11e-0f81-e053-2995a90a03bf	3
197818	indomethacin 50 MG Oral Capsule	SCD	205fc4e7-e118-509e-e063-6394a90a78e6	3
197818	indomethacin 50 MG Oral Capsule	PSN	9131abdc-dd9c-22f1-e053-2a95a90ab011	2
197818	indomethacin 50 MG Oral Capsule	SCD	9131abdc-dd9c-22f1-e053-2a95a90ab011	2
197818	indomethacin 50 MG Oral Capsule	PSN	971c4d53-7876-4f42-ba2d-c391714fa341	1
197818	indomethacin 50 MG Oral Capsule	SCD	971c4d53-7876-4f42-ba2d-c391714fa341	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-543-01	31722054301	12 BOTTLE in 1 CASE (31722-543-01) / 100 CAPSULE in 1 BOTTLE	12 bottle	2016-05-19	0000-00-00	No	No	Current
31722-543-05	31722054305	12 BOTTLE in 1 CASE (31722-543-05) / 500 CAPSULE in 1 BOTTLE	12 bottle	2016-05-19	0000-00-00	No	No	Current
31722-543-10	31722054310	12 BOTTLE in 1 CASE (31722-543-10) / 1000 CAPSULE in 1 BOTTLE	12 bottle	2016-05-19	0000-00-00	No	No	Current
31722-543-30	31722054330	12 BOTTLE in 1 CASE (31722-543-30) / 30 CAPSULE in 1 BOTTLE	12 bottle	2016-05-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Indomethacin	A-S Medication Solutions	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	35
Indomethacin	St. Mary's Medical Park Pharmacy	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	4
Indomethacin	PD-Rx Pharmaceuticals, Inc.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	15
INDOMETHACIN	DIRECT RX	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	7
Indomethacin	Preferred Pharmaceuticals Inc.	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	1
Indomethacin	A-S Medication Solutions	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	22
Indomethacin	Bryant Ranch Prepack	2025-09-26	HUMAN PRESCRIPTION DRUG LABEL	9
Indomethacin	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2025-05-08	HUMAN PRESCRIPTION DRUG LABEL	8
Indomethacin	Bryant Ranch Prepack	2025-03-31	HUMAN PRESCRIPTION DRUG LABEL	101
Indomethacin	Bryant Ranch Prepack	2025-03-28	Human Prescription Drug Label	4
Indomethacin	Bryant Ranch Prepack	2025-03-27	HUMAN PRESCRIPTION DRUG LABEL	102
Indomethacin	AvPAK	2025-02-13	HUMAN PRESCRIPTION DRUG LABEL	7
Indomethacin	Bryant Ranch Prepack	2024-08-19	HUMAN PRESCRIPTION DRUG LABEL	106
Indomethacin Capsule, USP Rx only	NuCare Pharmaceuticals, Inc. \| NuCare Pharmaceuticas, Inc.	2024-08-13	HUMAN PRESCRIPTION DRUG LABEL	5
Indomethacin 50mg	RedPharm Drug, Inc.	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	3
Indomethacin	Preferred Pharmaceuticals, Inc.	2024-05-24	HUMAN PRESCRIPTION DRUG LABEL	4
Indomethacin	REMEDYREPACK INC.	2024-03-15	HUMAN PRESCRIPTION DRUG LABEL	6
Indomethacin	RPK Pharmaceuticals, Inc.	2023-01-31	HUMAN PRESCRIPTION DRUG LABEL	4
Indomethacin Capsule, USP Rx only	Proficient Rx LP	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	6
Indomethacin Capsule, USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	3