nitrofurantoin macrocrystals
- Product NDC
- 51655-948
- 11-digit product format
- 516550948
- Labeler code
- 51655
- Product ID
- 51655-948_49748854-b59f-adc7-e063-6394a90afab7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- NDA016620
- Marketing category
- NDA
- Marketing start
- 2023-02-20
- Substance
- NITROFURANTOIN
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-948-20 | nitrofurantoin macrocrystals | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 5 |
| 51655-948-29 | nitrofurantoin macrocrystals | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 5 |
| 51655-948-53 | nitrofurantoin macrocrystals | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 5 |
| 51655-948-84 | nitrofurantoin macrocrystals | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-948 | NITROFURANTOIN MACROCRYSTALS CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] | 4 | Current NDC, 4 package rows | 20241228_f78102eb-cbed-801a-e053-6294a90ab880.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 |
|---|
| 51655-948-20 | 51655094820 | 20 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-20) | 20 capsule | 2023-02-20 | No | No | Historical |
| 51655-948-29 | 51655094829 | 28 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-29) | 28 capsule | 2023-02-20 | No | No | Historical |
| 51655-948-53 | 51655094853 | 10 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-53) | 10 capsule | 2023-08-31 | No | No | Historical |
| 51655-948-84 | 51655094884 | 14 CAPSULE in 1 BOTTLE, PLASTIC (51655-948-84) | 14 capsule | 2023-05-09 | No | No | Historical |