NDC 35356-697

Indomethacin

Indomethacin

Indomethacin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Indomethacin.

• Product ID: 35356-697_286c4f19-4b7a-4232-ba80-eb45a6bbbd71
• NDC: 35356-697
• Product Type: Human Prescription Drug
• Proprietary Name: Indomethacin
• Generic Name: Indomethacin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2010-12-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091276
• Labeler Name: Lake Erie Medical DBA Quality Care Products LLC
• Substance Name: INDOMETHACIN
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 35356-697-15

15 CAPSULE in 1 BOTTLE (35356-697-15)

• Marketing Start Date: 2010-12-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 35356-697-21 [35356069721]

Indomethacin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA091276
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-12-22
• Marketing End Date: 2019-10-11

NDC 35356-697-15 [35356069715]

Indomethacin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA091276
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-12-22

NDC 35356-697-50 [35356069750]

Indomethacin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA091276
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-12-22
• Marketing End Date: 2015-12-31

NDC 35356-697-30 [35356069730]

Indomethacin CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA091276
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-12-22

Drug Details

Active Ingredients

Ingredient	Strength
INDOMETHACIN	50 mg/1

OpenFDA Data

• SPL SET ID: b5e53529-e370-4916-a23c-8c9d945f971c
• Manufacturer:
  • Lake Erie Medical DBA Quality Care Products LLC
• UNII:
  • XXE1CET956
• RxNorm Concept Unique ID - RxCUI:
  • 197818
• 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