NDC 16571-072

Cefaclor

Cefaclor

Cefaclor is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Pack Pharmaceuticals, Llc. The primary component is Cefaclor.

• Product ID: 16571-072_309bc345-79d1-4e7a-80fc-cfafd8e1010b
• NDC: 16571-072
• Product Type: Human Prescription Drug
• Proprietary Name: Cefaclor
• Generic Name: Cefaclor
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2012-10-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065412
• Labeler Name: Pack Pharmaceuticals, LLC
• Substance Name: CEFACLOR
• Active Ingredient Strength: 375 mg/5mL
• Pharm Classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 16571-072-11

100 mL in 1 BOTTLE (16571-072-11)

• Marketing Start Date: 2012-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16571-072-11 [16571007211]

Cefaclor SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA065412
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-10-31
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CEFACLOR	375 mg/5mL

OpenFDA Data

• SPL SET ID: ac5e34a9-994b-4611-aa41-3d1ed58a91c0
• Manufacturer:
  • Pack Pharmaceuticals, LLC
• UNII:
  • 69K7K19H4L
• RxNorm Concept Unique ID - RxCUI:
  • 309044
  • 309042
  • 313888

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]

NDC Crossover Matching brand name "Cefaclor" or generic name "Cefaclor"

NDC	Brand Name	Generic Name
0093-1087	Cefaclor	Cefaclor
0143-9985	CEFACLOR	CEFACLOR
0143-9986	CEFACLOR	CEFACLOR
16571-070	Cefaclor	Cefaclor
16571-071	Cefaclor	Cefaclor
16571-072	Cefaclor	Cefaclor
21695-782	CEFACLOR	CEFACLOR
23594-125	Cefaclor	cefaclor
23594-250	Cefaclor	cefaclor
23594-375	Cefaclor	cefaclor
43063-194	CEFACLOR	CEFACLOR
50090-0518	CEFACLOR	CEFACLOR
50090-1602	Cefaclor	Cefaclor
59115-071	CEFACLOR	CEFACLOR
59115-072	CEFACLOR	CEFACLOR
61442-171	Cefaclor	Cefaclor
61442-172	Cefaclor	Cefaclor
61442-173	Cefaclor	Cefaclor
61442-174	Cefaclor	Cefaclor
61442-175	Cefaclor	Cefaclor
61442-176	Cefaclor	Cefaclor
63629-1007	Cefaclor	Cefaclor
68289-003	Cefaclor	cefaclor
68289-004	Cefaclor	cefaclor
81948-6250	Cefaclor	cefaclor