Nitrofurantoin
- Product NDC
- 70518-0799
- 11-digit product format
- 705180799
- Labeler code
- 70518
- Product ID
- 70518-0799_8ec9c630-c948-5f12-e053-2995a90a6f3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin monohydrate/macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207372
- Marketing category
- ANDA
- Marketing start
- 2017-10-19
- Marketing end
- 0000-00-00
- Substance
- NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
- Active strength
- 75 mg/1; mg/1
- Pharmacologic classes
- Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record