NDC 69097-965

Nabumetone

Nabumetone

Nabumetone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Nabumetone.

• Product ID: 69097-965_5a9cecab-f412-4dfe-ace3-7de5c8106c0a
• NDC: 69097-965
• Product Type: Human Prescription Drug
• Proprietary Name: Nabumetone
• Generic Name: Nabumetone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078671
• Labeler Name: Cipla USA Inc.
• Substance Name: NABUMETONE
• Active Ingredient Strength: 500 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: 2022-12-31

Packaging

NDC 69097-965-07

100 TABLET, FILM COATED in 1 BOTTLE (69097-965-07)

• Marketing Start Date: 2019-03-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69097-965-07 [69097096507]

Nabumetone TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078671
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-06

NDC 69097-965-12 [69097096512]

Nabumetone TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078671
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-06

Drug Details

Active Ingredients

Ingredient	Strength
NABUMETONE	500 mg/1

OpenFDA Data

• SPL SET ID: 85954380-a520-46d7-89ac-e4b19d6e00a1
• Manufacturer:
  • Cipla USA Inc.
• UNII:
  • LW0TIW155Z
• RxNorm Concept Unique ID - RxCUI:
  • 311892
  • 311893
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• UPC Code:
  • 0369097965075
• 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]
• Cyclooxygenase Inhibitors [MoA]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]

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

NDC	Brand Name	Generic Name
0115-1657	Nabumetone	Nabumetone
0115-1658	Nabumetone	Nabumetone
0185-0145	Nabumetone	Nabumentone
0185-0146	Nabumetone	Nabumentone
0440-5843	Nabumetone	Nabumetone
0440-5844	Nabumetone	Nabumetone
0591-3670	Nabumetone	Nabumetone
0591-3671	Nabumetone	Nabumetone
0615-7630	Nabumetone	nabumetone
0615-7645	Nabumetone	nabumetone
0615-7666	Nabumetone	Nabumetone
0615-7667	Nabumetone	Nabumetone
10544-003	Nabumetone	Nabumetone
10544-120	Nabumetone	Nabumetone
10544-271	Nabumetone	Nabumetone
10544-273	Nabumetone	Nabumetone
21695-230	Nabumetone	Nabumetone
21695-231	Nabumetone	Nabumetone
33261-077	Nabumetone	Nabumetone
33261-078	Nabumetone	Nabumetone
33358-251	Nabumetone	Nabumetone
33358-252	Nabumetone	Nabumetone
35356-685	Nabumetone	Nabumentone
35356-686	Nabumetone	Nabumetone
35356-687	Nabumetone	Nabumetone
35356-726	Nabumetone	Nabumetone
68084-051	Nabumetone	Nabumetone
68151-0574	Nabumetone	Nabumetone
68180-142	Nabumetone	Nabumetone
68180-141	Nabumetone	Nabumetone
68462-359	Nabumetone	Nabumetone
68462-358	Nabumetone	Nabumetone
68788-7220	Nabumetone	Nabumetone
68788-9909	Nabumetone	Nabumetone
68788-9908	Nabumetone	Nabumetone
69097-965	Nabumetone	Nabumetone
69097-966	Nabumetone	Nabumetone
70518-0934	Nabumetone	Nabumetone
70518-0614	Nabumetone	Nabumetone
70518-0698	Nabumetone	Nabumetone
70934-013	Nabumetone	Nabumetone
71205-030	Nabumetone	Nabumetone
71335-0781	Nabumetone	Nabumetone
71335-0531	Nabumetone	Nabumetone
71335-0754	Nabumetone	Nabumetone
71335-0939	Nabumetone	Nabumetone
76282-258	Nabumetone	Nabumetone
76282-257	Nabumetone	Nabumetone
43063-859	Nabumetone	Nabumetone
45865-351	Nabumetone	Nabumetone