NDC 70518-0515

Indomethacin

Indomethacin

Indomethacin is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Indomethacin.

• Product ID: 70518-0515_4f4b2ad9-48ee-002e-e054-00144ff88e88
• NDC: 70518-0515
• Product Type: Human Prescription Drug
• Proprietary Name: Indomethacin
• Generic Name: Indomethacin
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-05-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201807
• Labeler Name: REMEDYREPACK INC.
• Substance Name: INDOMETHACIN
• Active Ingredient Strength: 75 mg/1
• Pharm Classes: Cyclooxygenase
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 70518-0515-0

15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0515-0)

• Marketing Start Date: 2017-05-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0515-2 [70518051502]

Indomethacin CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA201807
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-10

NDC 70518-0515-1 [70518051501]

Indomethacin CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA201807
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-22

NDC 70518-0515-0 [70518051500]

Indomethacin CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA201807
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-10

Drug Details

Active Ingredients

Ingredient	Strength
INDOMETHACIN	75 mg/1

OpenFDA Data

• SPL SET ID: b3d4fbff-d9d5-4dbb-bf01-ca2efc3bcf30
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • XXE1CET956
• RxNorm Concept Unique ID - RxCUI:
  • 310992
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "Indomethacin" or generic name "Indomethacin"

NDC	Brand Name	Generic Name
0185-0720	Indomethacin	Indomethacin
0378-0143	Indomethacin	indomethacin
0378-0147	Indomethacin	indomethacin
0409-1113	Indomethacin	Indomethacin
0440-1652	Indomethacin	indomethacin
0713-0176	INDOMETHACIN	INDOMETHACIN
10544-083	Indomethacin	Indomethacin
10544-216	Indomethacin	indomethacin
10544-234	Indomethacin	indomethacin
10544-919	Indomethacin	Indomethacin
10544-935	Indomethacin	Indomethacin
10702-016	INDOMETHACIN	Indomethacin
21695-522	Indomethacin	Indomethacin
21695-523	Indomethacin	Indomethacin
23155-010	Indomethacin	Indomethacin
23155-011	Indomethacin	Indomethacin
31722-542	Indomethacin	Indomethacin
31722-543	Indomethacin	Indomethacin
31722-565	Indomethacin	Indomethacin
33261-133	Indomethacin	indomethacin
35356-697	Indomethacin	Indomethacin
42254-081	Indomethacin	Indomethacin
42254-237	INDOMETHACIN	indomethacin
42708-030	indomethacin	indomethacin
43063-368	Indomethacin	Indomethacin
68071-3060	Indomethacin	Indomethacin
68071-3277	Indomethacin	Indomethacin
68071-4091	indomethacin	indomethacin
68071-4394	Indomethacin	Indomethacin
68084-411	Indomethacin	Indomethacin
68151-0279	Indomethacin	Indomethacin
68151-2919	Indomethacin	Indomethacin
68151-1733	INDOMETHACIN	INDOMETHACIN
68382-293	indomethacin	indomethacin
68382-294	indomethacin	indomethacin
68382-371	indomethacin	indomethacin
68382-470	INDOMETHACIN	INDOMETHACIN
68462-302	Indomethacin	Indomethacin
68462-325	indomethacin	indomethacin
68462-406	Indomethacin	Indomethacin
68788-6448	Indomethacin	Indomethacin
68788-6983	Indomethacin	Indomethacin
68788-6821	Indomethacin	Indomethacin
68788-9107	INDOMETHACIN	INDOMETHACIN
68788-9108	INDOMETHACIN	INDOMETHACIN
70518-0254	Indomethacin	Indomethacin
70518-0515	Indomethacin	Indomethacin
70518-1458	Indomethacin	Indomethacin
70518-1512	Indomethacin	Indomethacin
70771-1203	indomethacin	indomethacin