NDC 68387-345

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 Keltman Pharmaceuticals Inc.. The primary component is Indomethacin.

• Product ID: 68387-345_7e1f7076-7c07-4f46-ba25-9dd18aa47baa
• NDC: 68387-345
• 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: 2006-01-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074464
• Labeler Name: Keltman Pharmaceuticals Inc.
• Substance Name: INDOMETHACIN
• Active Ingredient Strength: 75 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68387-345-30

30 CAPSULE in 1 BOTTLE, PLASTIC (68387-345-30)

• Marketing Start Date: 2006-01-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68387-345-30 [68387034530]

Indomethacin extended-release CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA074464
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-01-09
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
INDOMETHACIN	75 mg/1

OpenFDA Data

• SPL SET ID: 3125cb9f-d00c-47e7-9927-fbe38cadb48b
• Manufacturer:
  • Keltman Pharmaceuticals 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 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