Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 68084-446
- 11-digit product format
- 680840446
- Labeler code
- 68084
- Product ID
- 68084-446_eb6b1a55-8c09-3501-e053-2995a90a30d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA077066
- Marketing category
- ANDA
- Marketing start
- 2010-10-04
- Marketing end
- 2023-08-31
- Substance
- NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
- Active strength
- 25 mg/1; mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-446-01 | 68084044601 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-446-01) > 1 CAPSULE in 1 BLISTER PACK (68084-446-11) | 100 blister pack | 2010-10-04 | 0000-00-00 | No | No | Current |