nitrofurantoin (macrocrystals)
- Product NDC
- 59651-753
- 11-digit product format
- 596510753
- Labeler code
- 59651
- Product ID
- 59651-753_bac7a3bd-df62-4b82-853c-f4d6ea650c62
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin (macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA074967
- Marketing category
- ANDA
- Marketing start
- 2023-05-12
- Substance
- NITROFURANTOIN
- Active strength
- 50 mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], 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 (macrocrystals)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 311995 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-753-01 | nitrofurantoin (macrocrystals) | 100 in 1 BOTTLE | CAPSULE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-753 | NITROFURANTOIN (MACROCRYSTALS) CAPSULE [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, 1 package rows | 20230526_158e08ff-9b6d-4d60-a218-74dc289cf023.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 |
|---|
| 59651-753-01 | 59651075301 | 100 CAPSULE in 1 BOTTLE (59651-753-01) | 100 capsule | 2023-05-12 | No | No | Current |