NITROFURANTOIN (monohydrate/macrocrystals)
- Product NDC
- 67296-2180
- 11-digit product format
- 672962180
- Labeler code
- 67296
- Product ID
- 67296-2180_44f6672a-3bb0-4beb-e063-6394a90aca9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Redpharm Drug
- Application
- ANDA211013
- Marketing category
- ANDA
- Marketing start
- 2022-02-22
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NITROFURANTOIN (monohydrate/macrocrystals)
- Listing expiration
- 2026-12-31
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 |
|---|
| 67296-2180-1 | NITROFURANTOIN (monohydrate/macrocrystals) | 10 in 1 BOTTLE | CAPSULE | 10 | | 2 |
| 67296-2180-4 | NITROFURANTOIN (monohydrate/macrocrystals) | 14 in 1 BOTTLE | CAPSULE | 14 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67296-2180-1 | 67296218001 | 10 CAPSULE in 1 BOTTLE (67296-2180-1) | 10 capsule | 2022-02-22 | No | No | Historical |
| 67296-2180-4 | 67296218004 | 14 CAPSULE in 1 BOTTLE (67296-2180-4) | 14 capsule | 2022-02-22 | No | No | Historical |