NDC 59115-071

CEFACLOR

Cefaclor

CEFACLOR is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceutical. The primary component is Cefaclor.

• Product ID: 59115-071_1ba7db86-11d0-4eb5-a4a1-96d7bf17523f
• NDC: 59115-071
• Product Type: Human Prescription Drug
• Proprietary Name: CEFACLOR
• Generic Name: Cefaclor
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-07-07
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065350
• Labeler Name: Hikma Pharmaceutical
• Substance Name: CEFACLOR
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59115-071-15

15 CAPSULE in 1 BOTTLE (59115-071-15)

• Marketing Start Date: 2015-07-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59115-071-01 [59115007101]

CEFACLOR CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA065350
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-07-07

NDC 59115-071-15 [59115007115]

CEFACLOR CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA065350
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-07-07

Drug Details

Active Ingredients

Ingredient	Strength
CEFACLOR	500 mg/1

OpenFDA Data

• SPL SET ID: 78752b32-6295-4e27-ad4c-7723c433930d
• Manufacturer:
  • Hikma Pharmaceutical
• UNII:
  • 69K7K19H4L
• RxNorm Concept Unique ID - RxCUI:
  • 309045
  • 197449
• UPC Code:
  • 0359115072014

Pharmacological Class

• Cephalosporin Antibacterial [EPC]
• Cephalosporins [CS]
• 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