NDC 68001-386

Nitrofurantion

Nitrofurantion

Nitrofurantion is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bluepoint Labortories. The primary component is Nitrofurantoin.

• Product ID: 68001-386_ad020393-1c97-49da-b0f3-d6a9359fb73d
• NDC: 68001-386
• Product Type: Human Prescription Drug
• Proprietary Name: Nitrofurantion
• Generic Name: Nitrofurantion
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201722
• Labeler Name: BluePoint Labortories
• Substance Name: NITROFURANTOIN
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68001-386-00

100 CAPSULE in 1 BOTTLE (68001-386-00)

• Marketing Start Date: 2019-05-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68001-386-00 [68001038600]

Nitrofurantion CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA201722
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-14

Drug Details

Active Ingredients

Ingredient	Strength
NITROFURANTOIN	100 mg/1

OpenFDA Data

• SPL SET ID: ad020393-1c97-49da-b0f3-d6a9359fb73d
• Manufacturer:
  • BluePoint Labortories
• UNII:
  • 927AH8112L
• RxNorm Concept Unique ID - RxCUI:
  • 1648759
  • 311995
  • 311994
• UPC Code:
  • 0368001385008
  • 0368001386005

Pharmacological Class

• Nitrofurans [CS]
• Nitrofuran Antibacterial [EPC]
• Nitrofurans [CS]
• Nitrofuran Antibacterial [EPC]

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

NDC	Brand Name	Generic Name
50090-5693	Nitrofurantion	Nitrofurantion
55700-893	Nitrofurantion	Nitrofurantion
57664-231	Nitrofurantion	Nitrofurantion
57664-232	Nitrofurantion	Nitrofurantion
57664-233	Nitrofurantion	Nitrofurantion
61919-024	NITROFURANTION	NITROFURANTION
68001-384	Nitrofurantion	Nitrofurantion
68001-385	Nitrofurantion	Nitrofurantion
68001-386	Nitrofurantion	Nitrofurantion
68071-2363	Nitrofurantion	Nitrofurantion
68071-2647	Nitrofurantion	Nitrofurantion
68071-3134	Nitrofurantion	Nitrofurantion
70518-3041	Nitrofurantion	Nitrofurantion
70934-413	Nitrofurantion	Nitrofurantion
71205-171	Nitrofurantion	Nitrofurantion
71335-0024	Nitrofurantion	Nitrofurantion
71335-0793	Nitrofurantion	Nitrofurantion