Indomethacin

Product NDC: 31722-542
11-digit product format: 317220542
Labeler code: 31722
Product ID: 31722-542_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: 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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Indomethacin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
INDOMETHACIN	25 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	XXE1CET956
Rxcui	197817, 197818

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
31722-542-01	Indomethacin	12 in 1 CASE	CAPSULE	12	8
31722-542-01	Indomethacin	100 in 1 BOTTLE	CAPSULE	100	8
31722-542-05	Indomethacin	500 in 1 BOTTLE	CAPSULE	500	8
31722-542-05	Indomethacin	12 in 1 CASE	CAPSULE	12	8
31722-542-10	Indomethacin	12 in 1 CASE	CAPSULE	12	8
31722-542-10	Indomethacin	1000 in 1 BOTTLE	CAPSULE	1000	8
31722-542-30	Indomethacin	12 in 1 CASE	CAPSULE	12	8
31722-542-30	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
31722-542-01	EA - Each	31722-542	523188bb-803e-4021-8a79-c9c1c0ed5d5c	1	2012-07-24
31722-542-10	EA - Each	31722-542	2b1aafab-6149-4575-88cb-2233cba71b02	1	2012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-542	INDOMETHACIN (INDOMETHACIN) CAPSULE [CAMBER PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 8 package rows	20250509_1ce9c3c5-0cf7-4760-988d-2559adcfb200.zip

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
197817	indomethacin 25 MG Oral Capsule	PSN	9236d783-d7b8-4486-94c6-5ecd876bc475	107
197817	indomethacin 25 MG Oral Capsule	SCD	9236d783-d7b8-4486-94c6-5ecd876bc475	107
197817	indomethacin 25 MG Oral Capsule	PSN	b1bb9349-21e4-4e6a-9916-3aac6c4d01b8	103
197817	indomethacin 25 MG Oral Capsule	SCD	b1bb9349-21e4-4e6a-9916-3aac6c4d01b8	103
197817	indomethacin 25 MG Oral Capsule	PSN	2f4a5796-5317-4caa-83e4-0595fe844df4	102
197817	indomethacin 25 MG Oral Capsule	PSN	56e19868-3973-4f1b-b80f-1f7daf1f1c22	102
197817	indomethacin 25 MG Oral Capsule	SCD	2f4a5796-5317-4caa-83e4-0595fe844df4	102
197817	indomethacin 25 MG Oral Capsule	SCD	56e19868-3973-4f1b-b80f-1f7daf1f1c22	102
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
197817	indomethacin 25 MG Oral Capsule	PSN	ce866d3a-7bea-4d82-9b7d-79e8a294c141	14
197817	indomethacin 25 MG Oral Capsule	SCD	ce866d3a-7bea-4d82-9b7d-79e8a294c141	14
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	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	bcaa0e51-a2fc-cf74-027a-1964e38c5e4e	7
197817	indomethacin 25 MG Oral Capsule	PSN	3785c914-0037-49ef-b6f5-a5e868ae490b	6
197817	indomethacin 25 MG Oral Capsule	PSN	52a2ac94-f8b9-35fb-e054-00144ff8d46c	6
197817	indomethacin 25 MG Oral Capsule	SCD	3785c914-0037-49ef-b6f5-a5e868ae490b	6
197817	indomethacin 25 MG Oral Capsule	SCD	52a2ac94-f8b9-35fb-e054-00144ff8d46c	6
197817	indomethacin 25 MG Oral Capsule	PSN	dffe9b95-3cb6-4c4e-e053-2a95a90a9328	5
197817	indomethacin 25 MG Oral Capsule	PSN	759479d4-a8c4-4c7a-8b4b-91fce63bc046	5
197817	indomethacin 25 MG Oral Capsule	PSN	8aa48212-19b0-4304-9c61-dcf4db2b19ea	5
197817	indomethacin 25 MG Oral Capsule	SCD	8aa48212-19b0-4304-9c61-dcf4db2b19ea	5
197817	indomethacin 25 MG Oral Capsule	SCD	759479d4-a8c4-4c7a-8b4b-91fce63bc046	5
197817	indomethacin 25 MG Oral Capsule	SCD	dffe9b95-3cb6-4c4e-e053-2a95a90a9328	5
197817	indomethacin 25 MG Oral Capsule	PSN	67b16cf2-e24c-4fe3-8d74-e63549b7659f	4
197817	indomethacin 25 MG Oral Capsule	PSN	3e8796a6-94c6-0db2-e054-00144ff88e88	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
197817	indomethacin 25 MG Oral Capsule	SCD	3e8796a6-94c6-0db2-e054-00144ff88e88	4
197818	indomethacin 50 MG Oral Capsule	SCD	67b16cf2-e24c-4fe3-8d74-e63549b7659f	4
197817	indomethacin 25 MG Oral Capsule	PSN	aa443877-b407-4ace-b162-9b2a3c89dc93	3
197817	indomethacin 25 MG Oral Capsule	SCD	aa443877-b407-4ace-b162-9b2a3c89dc93	3
197817	indomethacin 25 MG Oral Capsule	PSN	9c15102c-b6f9-4198-b592-152160591014	1
197817	indomethacin 25 MG Oral Capsule	SCD	9c15102c-b6f9-4198-b592-152160591014	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-542-01	31722054201	12 BOTTLE in 1 CASE (31722-542-01) / 100 CAPSULE in 1 BOTTLE	12 bottle	2016-05-19	0000-00-00	No	No	Current
31722-542-05	31722054205	12 BOTTLE in 1 CASE (31722-542-05) / 500 CAPSULE in 1 BOTTLE	12 bottle	2016-05-19	0000-00-00	No	No	Current
31722-542-10	31722054210	12 BOTTLE in 1 CASE (31722-542-10) / 1000 CAPSULE in 1 BOTTLE	12 bottle	2016-05-19	0000-00-00	No	No	Current
31722-542-30	31722054230	12 BOTTLE in 1 CASE (31722-542-30) / 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	PD-Rx Pharmaceuticals, Inc.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	14
Indomethacin	A-S Medication Solutions	2026-05-15	HUMAN PRESCRIPTION DRUG LABEL	33
Indomethacin	Preferred Pharmaceuticals, Inc.	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	6
Indomethacin	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
Indomethacin	A-S Medication Solutions	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	22
Indomethacin	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2025-05-08	HUMAN PRESCRIPTION DRUG LABEL	8
Indomethacin	Bryant Ranch Prepack	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	103
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	2024-11-20	HUMAN PRESCRIPTION DRUG LABEL	107
Indomethacin	Bryant Ranch Prepack	2024-11-20	HUMAN PRESCRIPTION DRUG LABEL	102
Indomethacin Capsule, USP Rx only	NuCare Pharmaceuticals, Inc.	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	4
Indomethacin - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	6
Indomethacin	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Indomethacin	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Indomethacin Capsule, USP Rx only	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	5
INDOMETHACIN	Direct Rx	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	3

Indomethacin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#