Nitrofurantoin monohydrate/macrocrystals
- Product NDC
- 68071-4535
- 11-digit product format
- 680714535
- Labeler code
- 68071
- Product ID
- 68071-4535_bd9a558c-915e-ba5d-e053-2995a90adc51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin monohydrate/macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA207372
- Marketing category
- ANDA
- Marketing start
- 2017-05-25
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-4535-2 | 68071453502 | 2 CAPSULE in 1 BOTTLE (68071-4535-2) | 2 capsule | 2018-08-22 | 0000-00-00 | No | No | Current |
| 68071-4535-6 | 68071453506 | 6 CAPSULE in 1 BOTTLE (68071-4535-6) | 6 capsule | 2018-08-22 | 0000-00-00 | No | No | Current |