NDC 46084-021

APROFEN REGULAR STRENGTH

Ibuprofen

APROFEN REGULAR STRENGTH is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by A P J Laboratories Limited. The primary component is Ibuprofen.

• Product ID: 46084-021_496c0fce-ed16-49f1-89fd-946140bcdedc
• NDC: 46084-021
• Product Type: Human Otc Drug
• Proprietary Name: APROFEN REGULAR STRENGTH
• Generic Name: Ibuprofen
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-02-21
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part343
• Labeler Name: A P J Laboratories Limited
• Substance Name: IBUPROFEN
• Active Ingredient Strength: 200 mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 46084-021-31

2 TABLET in 1 BLISTER PACK (46084-021-31)

• Marketing Start Date: 2013-02-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46084-021-26 [46084002126]

APROFEN REGULAR STRENGTH TABLET

• Marketing Category: OTC monograph final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-02-21
• Inactivation Date: 2019-11-27

NDC 46084-021-22 [46084002122]

APROFEN REGULAR STRENGTH TABLET

• Marketing Category: OTC monograph final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-02-21
• Inactivation Date: 2019-11-27

NDC 46084-021-31 [46084002131]

APROFEN REGULAR STRENGTH TABLET

• Marketing Category: OTC monograph final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-02-21
• Inactivation Date: 2019-11-27

NDC 46084-021-23 [46084002123]

APROFEN REGULAR STRENGTH TABLET

• Marketing Category: OTC monograph final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-02-21
• Inactivation Date: 2019-11-27

NDC 46084-021-24 [46084002124]

APROFEN REGULAR STRENGTH TABLET

• Marketing Category: OTC monograph final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-02-21
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	200 mg/1

OpenFDA Data

• SPL SET ID: 57d4729d-044f-4ed7-bc93-67c1af9df84c
• Manufacturer:
  • A P J Laboratories Limited
• UNII:
  • WK2XYI10QM
• RxNorm Concept Unique ID - RxCUI:
  • 310965
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

NDC Crossover Matching brand name "APROFEN REGULAR STRENGTH" or generic name "Ibuprofen"

NDC	Brand Name	Generic Name
46084-021	APROFEN REGULAR STRENGTH	APROFEN REGULAR STRENGTH
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
0113-7131	basic care ibuprofen	Ibuprofen
0113-7517	basic care ibuprofen	Ibuprofen
0113-7604	Basic Care Ibuprofen	Ibuprofen
0121-0917	Childrens Ibuprofen	Ibuprofen
0121-0914	Childrens Ibuprofen Oral Suspension	Ibuprofen
0113-2461	Good Sense Childrens Ibuprofen	Ibuprofen
0113-0057	Good Sense ibuprofen	ibuprofen
0113-0074	Good Sense ibuprofen	Ibuprofen
0113-0166	good sense ibuprofen	Ibuprofen
0113-0298	good sense ibuprofen	Ibuprofen
0113-0461	Good Sense ibuprofen	Ibuprofen
0113-0517	Good Sense ibuprofen	Ibuprofen
0113-0604	good sense ibuprofen	Ibuprofen
0113-0647	good sense ibuprofen	Ibuprofen
0113-0660	Good Sense Ibuprofen	Ibuprofen
0113-0685	Good Sense Ibuprofen	Ibuprofen
0113-0897	good sense ibuprofen	Ibuprofen
0113-1212	Good Sense Ibuprofen	Ibuprofen
0113-4501	good sense ibuprofen	ibuprofen
0113-0040	Good Sense Infants Ibuprofen	Ibuprofen