NITROFURANTOIN
- Product NDC
- 50090-6750
- 11-digit product format
- 500906750
- Labeler code
- 50090
- Product ID
- 50090-6750_30cd4ffd-e29b-4e19-9120-4c052ce9efeb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NITROFURANTOIN
- 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 |
|---|
| 50090-6750-1 | NITROFURANTOIN | 10 in 1 BOTTLE | CAPSULE | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6750 | NITROFURANTOIN (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)) CAPSULE [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 1 package rows | 20231019_2a772eb3-4fb3-4d92-b9f4-469dd2216361.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 |
|---|
| 50090-6750-1 | 50090675001 | 10 CAPSULE in 1 BOTTLE (50090-6750-1) | 10 capsule | 2023-10-16 | No | No | Historical |