NITROFURANTOIN (monohydrate/macrocrystals)
- Product NDC
- 82868-065
- 11-digit product format
- 828680065
- Labeler code
- 82868
- Product ID
- 82868-065_4defca17-8c6e-2031-e063-6394a90ab1d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA211013
- Marketing category
- ANDA
- Marketing start
- 2024-10-16
- 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 |
|---|
| 82868-065-10 | NITROFURANTOIN (monohydrate/macrocrystals) | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 4 |
| 82868-065-14 | NITROFURANTOIN (monohydrate/macrocrystals) | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | | 4 |
| 82868-065-20 | NITROFURANTOIN (monohydrate/macrocrystals) | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-065 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 3 package rows | 20241024_25172572-dbdc-db70-e063-6394a90aa87b.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 |
|---|
| 82868-065-10 | 82868006510 | 10 CAPSULE in 1 BOTTLE, PLASTIC (82868-065-10) | 10 capsule | 2025-05-12 | No | No | Historical |
| 82868-065-14 | 82868006514 | 14 CAPSULE in 1 BOTTLE, PLASTIC (82868-065-14) | 14 capsule | 2024-10-16 | No | No | Historical |
| 82868-065-20 | 82868006520 | 20 CAPSULE in 1 BOTTLE, PLASTIC (82868-065-20) | 20 capsule | 2026-02-04 | No | No | Historical |