NDC 0185-0122

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 Eon Labs, Inc.. The primary component is Nitrofurantoin; Nitrofurantoin Monohydrate.

• Product ID: 0185-0122_7626a80c-83d9-45a6-b1bc-08705ae46bb5
• NDC: 0185-0122
• 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: 2005-04-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077066
• Labeler Name: Eon Labs, Inc.
• Substance Name: NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
• Active Ingredient Strength: 25 mg/1; mg/1
• Pharm Classes: Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2024-12-31

Packaging

NDC 0185-0122-01

100 CAPSULE in 1 BOTTLE (0185-0122-01)

• Marketing Start Date: 2005-04-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0185-0122-10 [00185012210]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA077066
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-04-06

NDC 0185-0122-01 [00185012201]

Nitrofurantoin (monohydrate/macrocrystals) CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA077066
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-04-06

Drug Details

Active Ingredients

Ingredient	Strength
NITROFURANTOIN MONOHYDRATE	75 mg/1

OpenFDA Data

• SPL SET ID: 7ba9a729-a73a-4a13-a336-0284cc8a67e1
• Manufacturer:
  • Eon Labs, Inc.
• UNII:
  • E1QI2CQQ1I
  • 927AH8112L
• RxNorm Concept Unique ID - RxCUI:
  • 1648755

Pharmacological Class

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