NDC 46084-091

IBUPROFEN COLD AND SINUS A P J

Ibuprofen, Pseudoephedrine Hydrochloride

IBUPROFEN COLD AND SINUS A P J is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by A P J Laboratories Limited. The primary component is Ibuprofen; Pseudoephedrine Hydrochloride.

• Product ID: 46084-091_14d51b10-696d-4626-bb3b-143cde538b2f
• NDC: 46084-091
• Product Type: Human Otc Drug
• Proprietary Name: IBUPROFEN COLD AND SINUS A P J
• Generic Name: Ibuprofen, Pseudoephedrine Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-06-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074567
• Labeler Name: A P J Laboratories Limited
• Substance Name: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 200 mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 46084-091-60

20 TABLET, COATED in 1 BLISTER PACK (46084-091-60)

• Marketing Start Date: 2013-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46084-091-60 [46084009160]

IBUPROFEN COLD AND SINUS A P J TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA074567
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-06-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	200 mg/1

OpenFDA Data

• SPL SET ID: db492dad-ab1c-459d-842c-062e4b3f4c57
• Manufacturer:
  • A P J Laboratories Limited
• UNII:
  • 6V9V2RYJ8N
  • WK2XYI10QM
• RxNorm Concept Unique ID - RxCUI:
  • 1299021
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

NDC Crossover Matching brand name "IBUPROFEN COLD AND SINUS A P J" or generic name "Ibuprofen, Pseudoephedrine Hydrochloride"

NDC	Brand Name	Generic Name
0573-0184	ADVIL COLD AND SINUS	ibuprofen, pseudoephedrine hydrochloride
68258-8902	Good Neighbor Pharmacy Ibuprofen Cold and Sinus	Ibuprofen, Pseudoephedrine Hydrochloride
46084-091	IBUPROFEN COLD AND SINUS	IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE