Nitrofurantoin Macrocrystals
- Product NDC
- 0115-1643
- 11-digit product format
- 001151643
- Labeler code
- 0115
- Product ID
- 0115-1643_151534e1-3754-4da0-8fca-8ade53adca20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA073671
- Marketing category
- ANDA
- Marketing start
- 2007-03-08
- Substance
- NITROFURANTOIN
- Active strength
- 50 mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], 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 Macrocrystals
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 311995, 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-1643-01 | Nitrofurantoin Macrocrystals | 100 in 1 BOTTLE | CAPSULE | 100 | | 15 |
| 0115-1643-03 | Nitrofurantoin Macrocrystals | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1643 | NITROFURANTOIN MACROCRYSTALS CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20231231_341c75ac-fba5-480d-a221-868c4195cb6f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-1643-01 | 00115164301 | 100 CAPSULE in 1 BOTTLE (0115-1643-01) | 100 capsule | 2007-03-08 | 0000-00-00 | No | No | Current |
| 0115-1643-03 | 00115164303 | 1000 CAPSULE in 1 BOTTLE (0115-1643-03) | 1000 capsule | 2007-03-08 | 0000-00-00 | No | No | Current |