Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 55700-822
- 11-digit product format
- 557000822
- Labeler code
- 55700
- Product ID
- 55700-822_6440cfbd-d3b5-4262-8542-2a815fa802f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA077066
- Marketing category
- ANDA
- Marketing start
- 2019-11-19
- 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
- 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 |
|---|
| 55700-822-14 | 55700082214 | 14 CAPSULE in 1 BOTTLE (55700-822-14) | 14 capsule | 2019-11-19 | 0000-00-00 | No | No | Current |
| 55700-822-20 | 55700082220 | 20 CAPSULE in 1 BOTTLE (55700-822-20) | 20 capsule | 2020-09-03 | 0000-00-00 | No | No | Current |