Nitrofurantoin Monohydrate/ Macrocrystalline
- Product NDC
- 0904-7137
- 11-digit product format
- 009047137
- Labeler code
- 0904
- Product ID
- 0904-7137_06bb1817-bab0-4230-971e-06feab3d3dcd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Monohydrate/Macrocrystalline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- NDA020064
- Marketing category
- NDA
- Marketing start
- 2011-05-25
- Marketing end
- 2026-05-31
- Substance
- NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
- Active strength
- 25; 75 mg/1; mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7137-61 | Nitrofurantoin Monohydrate/ Macrocrystalline | 100 in 1 CARTON | CAPSULE | 100 | | 4 |
| 0904-7137-61 | Nitrofurantoin Monohydrate/ Macrocrystalline | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7137 | NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [MAJOR PHARMACEUTICALS] | 2 | Current NDC, 2 package rows | 20240820_b2c95493-7bd7-414c-8ea8-61d55c5cedca.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-7137-61 | 00904713761 | 100 BLISTER PACK in 1 CARTON (0904-7137-61) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2023-06-05 | 2026-05-31 | No | No | Historical |