NDC 53002-3980

IBU

Ibuprofen

IBU is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Ibuprofen.

• Product ID: 53002-3980_792c9efc-44b8-4395-8348-f0af5d5f3ba2
• NDC: 53002-3980
• Product Type: Human Prescription Drug
• Proprietary Name: IBU
• Generic Name: Ibuprofen
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2008-11-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075682
• Labeler Name: RPK Pharmaceuticals, Inc.
• Substance Name: IBUPROFEN
• Active Ingredient Strength: 800 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 53002-3980-0

100 TABLET in 1 BOTTLE (53002-3980-0)

• Marketing Start Date: 2017-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53002-3980-2 [53002398002]

IBU TABLET

• Marketing Category: ANDA
• Application Number: ANDA075682
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

NDC 53002-3980-1 [53002398001]

IBU TABLET

• Marketing Category: ANDA
• Application Number: ANDA075682
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

NDC 53002-3980-3 [53002398003]

IBU TABLET

• Marketing Category: ANDA
• Application Number: ANDA075682
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

NDC 53002-3980-5 [53002398005]

IBU TABLET

• Marketing Category: ANDA
• Application Number: ANDA075682
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

NDC 53002-3980-0 [53002398000]

IBU TABLET

• Marketing Category: ANDA
• Application Number: ANDA075682
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	800 mg/1

OpenFDA Data

• SPL SET ID: 405074f3-9c1a-46cd-889e-76ec8966a556
• Manufacturer:
  • RPK Pharmaceuticals, Inc.
• UNII:
  • WK2XYI10QM
• RxNorm Concept Unique ID - RxCUI:
  • 197807
  • 197806
  • 206917
  • 206913
• 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]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]

NDC Crossover Matching brand name "IBU" or generic name "Ibuprofen"

NDC	Brand Name	Generic Name
68071-1827	IBU	IBU
68071-3053	IBU	IBU
68071-3125	IBU	IBU
68071-3172	IBU	IBU
70518-0490	IBU	IBU
70518-1145	IBU	IBU
10544-071	IBU	IBU
10544-625	IBU	IBU
35356-699	IBU	IBU
43353-273	IBU	IBU
49999-042	IBU	IBU
50436-0684	IBU	IBU
50436-4605	IBU	IBU
50436-4604	IBU	IBU
53002-3370	IBU	IBU
53002-3980	IBU	IBU
53002-3010	IBU	IBU
53217-366	IBU	IBU
55111-683	IBU	IBU
55111-684	IBU	IBU
55111-682	IBU	IBU
60429-219	IBU	IBU
60429-220	IBU	IBU
60429-221	IBU	IBU
60760-135	IBU	IBU
60760-076	IBU	IBU
61919-621	IBU	IBU
63187-614	IBU	IBU
66267-116	IBU	IBU
66267-117	IBU	IBU
66267-963	IBU	IBU
66267-793	IBU	IBU
66267-795	IBU	IBU
66267-964	IBU	IBU
66267-794	IBU	IBU
67296-1217	IBU	IBU
67296-0877	IBU	IBU
67296-0913	IBU	IBU
70934-195	IBU	IBU
71610-275	IBU	IBU
0615-8116	IBU	IBU
0615-8115	IBU	IBU
0615-8117	IBU	IBU
50090-4341	IBU	IBU
50090-4333	IBU	IBU
0113-1461	basic care childrens ibuprofen	Ibuprofen
0113-7619	basic care childrens ibuprofen	ibuprofen
0113-7660	basic care childrens ibuprofen	Ibuprofen
0113-7897	Basic Care childrens ibuprofen	Ibuprofen
0113-0788	Basic Care ibuprofen	Ibuprofen