NDC 68094-503

Childrens Ibuprofen

Ibuprofen

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: 68094-503_1440ed00-59c2-49da-8a67-67694ca1a641
• NDC: 68094-503
• Product Type: Human Otc Drug
• Proprietary Name: Childrens Ibuprofen
• Generic Name: Ibuprofen
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2006-09-14
• 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: 2024-12-31

Packaging

NDC 68094-503-61

10 TRAY in 1 CASE (68094-503-61) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)

• Marketing Start Date: 2006-09-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68094-503-62 [68094050362]

Childrens Ibuprofen SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA074937
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-09-14

NDC 68094-503-59 [68094050359]

Childrens Ibuprofen SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA074937
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-09-14

NDC 68094-503-61 [68094050361]

Childrens Ibuprofen SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA074937
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-09-14

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	200 mg/10mL

OpenFDA Data

• SPL SET ID: 1984374e-7639-4a4f-bf96-a614e663e0c4
• 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 "Childrens Ibuprofen" or generic name "Ibuprofen"

NDC	Brand Name	Generic Name
0121-0917	Childrens Ibuprofen	Ibuprofen
68016-255	Childrens Ibuprofen	Childrens Ibuprofen
68016-262	Childrens Ibuprofen	Childrens Ibuprofen
68016-250	Childrens Ibuprofen	Childrens Ibuprofen
68016-261	Childrens Ibuprofen	Childrens Ibuprofen
68016-263	Childrens Ibuprofen	Childrens Ibuprofen
68071-4217	Childrens Ibuprofen	Childrens Ibuprofen
68094-503	Childrens Ibuprofen	Childrens Ibuprofen
68094-494	Childrens Ibuprofen	Childrens Ibuprofen
0472-1255	Childrens Ibuprofen	Childrens Ibuprofen
0472-1263	Childrens Ibuprofen	Childrens Ibuprofen
0472-1261	Childrens Ibuprofen	Childrens Ibuprofen
68788-9109	Childrens Ibuprofen	Childrens Ibuprofen
69842-323	Childrens Ibuprofen	Childrens Ibuprofen
76413-344	Childrens Ibuprofen	Childrens Ibuprofen
11822-1261	Childrens Ibuprofen	Childrens Ibuprofen
11822-0166	Childrens Ibuprofen	Childrens Ibuprofen
0121-1836	Childrens Ibuprofen	Childrens Ibuprofen
37012-897	Childrens Ibuprofen	Childrens Ibuprofen
37012-166	childrens ibuprofen	childrens ibuprofen
37012-685	Childrens Ibuprofen	Childrens Ibuprofen
37808-200	childrens ibuprofen	childrens ibuprofen
41250-685	childrens ibuprofen	childrens ibuprofen
41250-419	Childrens Ibuprofen	Childrens Ibuprofen
41250-240	childrens ibuprofen	childrens ibuprofen
41250-626	childrens ibuprofen	childrens ibuprofen
45802-133	Childrens Ibuprofen	Childrens Ibuprofen
45802-140	Childrens Ibuprofen	Childrens Ibuprofen
49035-126	Childrens Ibuprofen	Childrens Ibuprofen
50090-2528	Childrens Ibuprofen	Childrens Ibuprofen
50090-3227	CHILDRENS IBUPROFEN	CHILDRENS IBUPROFEN
53041-634	Childrens Ibuprofen	Childrens Ibuprofen
55154-1585	Childrens Ibuprofen	Childrens Ibuprofen
55154-1577	Childrens Ibuprofen	Childrens Ibuprofen
55312-685	childrens ibuprofen	childrens ibuprofen
55319-150	Childrens Ibuprofen	Childrens Ibuprofen
55319-263	Childrens Ibuprofen	Childrens Ibuprofen
58602-200	CHILDRENS IBUPROFEN	CHILDRENS IBUPROFEN
58602-212	CHILDRENS IBUPROFEN	CHILDRENS IBUPROFEN
59779-882	Childrens Ibuprofen	Childrens Ibuprofen
59779-971	Childrens Ibuprofen	Childrens Ibuprofen
0363-1262	Childrens Ibuprofen	Childrens Ibuprofen
0363-1263	Childrens Ibuprofen	Childrens Ibuprofen
0363-1255	Childrens Ibuprofen	Childrens Ibuprofen
0363-1761	Childrens Ibuprofen	Childrens Ibuprofen
0363-1261	Childrens Ibuprofen	Childrens Ibuprofen
0363-1763	Childrens Ibuprofen	Childrens Ibuprofen
0363-1764	Childrens Ibuprofen	Childrens Ibuprofen
0363-1762	Childrens Ibuprofen	Childrens Ibuprofen
0363-7610	Childrens Ibuprofen	Childrens Ibuprofen