NDC 0378-8200

Ketoprofen

Ketoprofen

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

• Product ID: 0378-8200_2e0f7597-eca8-493d-a868-61b5b63144a0
• NDC: 0378-8200
• Product Type: Human Prescription Drug
• Proprietary Name: Ketoprofen
• Generic Name: Ketoprofen
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2003-09-04
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075679
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: KETOPROFEN
• Active Ingredient Strength: 200 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: 2021-12-31

Packaging

NDC 0378-8200-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)

• Marketing Start Date: 2003-09-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-8200-05 [00378820005]

Ketoprofen CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075679
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-09-04
• Marketing End Date: 2015-06-29

NDC 0378-8200-01 [00378820001]

Ketoprofen CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075679
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-09-04

Drug Details

Active Ingredients

Ingredient	Strength
KETOPROFEN	200 mg/1

OpenFDA Data

• SPL SET ID: 198a4140-f4c0-4478-9157-ee1d68d0bb96
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 90Y4QC304K
• RxNorm Concept Unique ID - RxCUI:
  • 359697
• 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 "Ketoprofen" or generic name "Ketoprofen"

NDC	Brand Name	Generic Name
0276-0504	Ketoprofen	Ketoprofen
0276-0506	Ketoprofen	Ketoprofen
0378-8200	Ketoprofen	ketoprofen
21695-340	Ketoprofen	ketoprofen
21695-341	Ketoprofen	ketoprofen
23155-020	ketoprofen	ketoprofen
23155-021	ketoprofen	ketoprofen
23155-022	ketoprofen	ketoprofen
33261-064	Ketoprofen	Ketoprofen
42254-037	Ketoprofen	Ketoprofen
43063-737	Ketoprofen	Ketoprofen
45865-379	Ketoprofen	Ketoprofen
45865-485	Ketoprofen	Ketoprofen
50090-2729	Ketoprofen	Ketoprofen
52959-245	Ketoprofen	Ketoprofen
53217-221	Ketoprofen	Ketoprofen
63187-018	Ketoprofen	Ketoprofen
63629-1836	Ketoprofen	Ketoprofen
63629-3642	Ketoprofen	Ketoprofen
66267-126	Ketoprofen	Ketoprofen
67296-0369	Ketoprofen	Ketoprofen
68788-6400	Ketoprofen	Ketoprofen
68788-9088	Ketoprofen	Ketoprofen
69336-127	Ketoprofen	Ketoprofen