NDC 68094-600

Dye Free Childrens Ibuprofen

Ibuprofen

Dye Free Childrens Ibuprofen is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Precision Dose Inc.. The primary component is Ibuprofen.

• Product ID: 68094-600_20ac0a1c-81ab-4b54-80a0-abd0f5243ed6
• NDC: 68094-600
• Product Type: Human Otc Drug
• Proprietary Name: Dye Free Childrens Ibuprofen
• Generic Name: Ibuprofen
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074937
• Labeler Name: Precision Dose Inc.
• Substance Name: IBUPROFEN
• Active Ingredient Strength: 100 mg/5mL
• Pharm Classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 68094-600-61

10 TRAY in 1 CASE (68094-600-61) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-600-59)

• Marketing Start Date: 2015-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68094-600-61 [68094060061]

Dye Free Childrens Ibuprofen SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA074937
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-08-26

NDC 68094-600-62 [68094060062]

Dye Free Childrens Ibuprofen SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA074937
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-08-26

NDC 68094-600-59 [68094060059]

Dye Free Childrens Ibuprofen SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA074937
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-08-26

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	100 mg/5mL

OpenFDA Data

• SPL SET ID: eccee4c6-aa94-468a-aebd-265d7a9efb6d
• Manufacturer:
  • Precision Dose Inc.
• UNII:
  • WK2XYI10QM
• RxNorm Concept Unique ID - RxCUI:
  • 197803
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

NDC Crossover Matching brand name "Dye Free Childrens Ibuprofen" or generic name "Ibuprofen"

NDC	Brand Name	Generic Name
68094-600	Dye Free Childrens Ibuprofen	Dye Free Childrens Ibuprofen
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