Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 82868-012
- 11-digit product format
- 828680012
- Labeler code
- 82868
- Product ID
- 82868-012_48344cd1-d22b-7c9f-e063-6394a90af908
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA077066
- Marketing category
- ANDA
- Marketing start
- 2023-08-30
- 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nitrofurantoin (monohydrate/macrocrystals)
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 25 mg/1 |
| NITROFURANTOIN MONOHYDRATE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L, E1QI2CQQ1I |
| Rxcui | 1648755 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82868-012-10 | Nitrofurantoin (monohydrate/macrocrystals) | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 4 |
| 82868-012-14 | Nitrofurantoin (monohydrate/macrocrystals) | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-012 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 1 package rows | 20250101_04b4189e-9b21-78ed-e063-6394a90ab8e0.zip |
| 82868-012 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 1 package rows | 20250101_0631d961-ef23-8f2a-e063-6294a90aa0a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82868-012-10 | 82868001210 | 10 CAPSULE in 1 BOTTLE, PLASTIC (82868-012-10) | 10 capsule | 2023-08-30 | No | No | Historical |
| 82868-012-14 | 82868001214 | 14 CAPSULE in 1 BOTTLE, PLASTIC (82868-012-14) | 14 capsule | 2023-09-20 | No | No | Historical |