NDC 70934-269

Nitrofurantoin (monohydrate/macrocrystals)

Nitrofurantoin (monohydrate/macrocrystals)

Nitrofurantoin (monohydrate/macrocrystals) is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. The primary component is Nitrofurantoin Monohydrate; Nitrofurantoin.

• Product ID: 70934-269_8aaae234-f3cb-14e8-e053-2a95a90a1914
• NDC: 70934-269
• Product Type: Human Prescription Drug
• Proprietary Name: Nitrofurantoin (monohydrate/macrocrystals)
• Generic Name: Nitrofurantoin (monohydrate/macrocrystals)
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-02-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077066
• Labeler Name: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
• Substance Name: NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
• Active Ingredient Strength: 75 mg/1; mg/1
• Pharm Classes: Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70934-269-02

2 CAPSULE in 1 BOTTLE, PLASTIC (70934-269-02)

• Marketing Start Date: 2019-02-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70934-269-14 [70934026914]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA077066
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-14

NDC 70934-269-02 [70934026902]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA077066
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-14

NDC 70934-269-10 [70934026910]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA077066
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-17

Drug Details

Active Ingredients

Ingredient	Strength
NITROFURANTOIN MONOHYDRATE	75 mg/1

OpenFDA Data

• SPL SET ID: 8aaae234-f3ca-14e8-e053-2a95a90a1914
• Manufacturer:
  • Denton Pharma, Inc. DBA Northwind Pharmaceuticals
• UNII:
  • E1QI2CQQ1I
  • 927AH8112L

Pharmacological Class

• Nitrofurans [CS]
• Nitrofuran Antibacterial [EPC]

NDC Crossover Matching brand name "Nitrofurantoin (monohydrate/macrocrystals)" or generic name "Nitrofurantoin (monohydrate/macrocrystals)"

NDC	Brand Name	Generic Name
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
0480-3470	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
16714-439	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
21695-300	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
55700-822	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
59746-762	NITROFURANTOIN (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
60760-194	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
63187-995	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
63629-1459	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
63629-1748	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
68071-4367	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
68071-4428	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
68071-5076	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
68071-4531	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
70518-0799	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
70934-129	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
71335-0863	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
42291-574	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
50268-625	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
53002-7042	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
60760-478	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
65162-478	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
67296-1640	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
70934-269	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
55700-794	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
50090-4570	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)
50090-3737	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)
50090-3856	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)
53002-7041	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)
63629-7968	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)