NDC 59746-379

Indomethacin extended-release

Indomethacin Extended-release

Indomethacin extended-release is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Jubilant Cadista Pharmaceuticals Inc.. The primary component is Indomethacin.

• Product ID: 59746-379_7275b33f-ac32-4f0f-832c-22077e2edc5e
• NDC: 59746-379
• Product Type: Human Prescription Drug
• Proprietary Name: Indomethacin extended-release
• Generic Name: Indomethacin Extended-release
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-10-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202706
• Labeler Name: Jubilant Cadista Pharmaceuticals Inc.
• Substance Name: INDOMETHACIN
• Active Ingredient Strength: 75 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59746-379-01

100 CAPSULE in 1 BOTTLE (59746-379-01)

• Marketing Start Date: 2015-10-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59746-379-01 [59746037901]

Indomethacin extended-release CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA202706
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-10-05

NDC 59746-379-60 [59746037960]

Indomethacin extended-release CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA202706
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-05

NDC 59746-379-90 [59746037990]

Indomethacin extended-release CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA202706
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-05

NDC 59746-379-05 [59746037905]

Indomethacin extended-release CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA202706
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-10-05

Drug Details

Active Ingredients

Ingredient	Strength
INDOMETHACIN	75 mg/1

OpenFDA Data

• SPL SET ID: 7b61c038-717c-0dee-4cab-d6aa55cbf28a
• Manufacturer:
  • Jubilant Cadista Pharmaceuticals Inc.
• UNII:
  • XXE1CET956
• RxNorm Concept Unique ID - RxCUI:
  • 310992
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• UPC Code:
  • 0359746379056
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]

Medicade Reported Pricing

59746037990 INDOMETHACIN ER 75 MG CAPSULE

Pricing Unit: EA | Drug Type:

59746037960 INDOMETHACIN ER 75 MG CAPSULE

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Indomethacin extended-release" or generic name "Indomethacin Extended-release"

NDC	Brand Name	Generic Name
52959-082	INDOMETHACIN EXTENDED-RELEASE	INDOMETHACIN EXTENDED-RELEASE
59746-379	Indomethacin extended-release	Indomethacin extended-release
65862-684	Indomethacin Extended-Release	Indomethacin Extended-Release
68071-3174	Indomethacin extended-release	Indomethacin extended-release
68387-345	Indomethacin extended-release	Indomethacin extended-release
71335-0137	Indomethacin extended-release	Indomethacin extended-release