nitrofurantoin macrocrystals
- Product NDC
- 71335-2254
- 11-digit product format
- 713352254
- Labeler code
- 71335
- Product ID
- 71335-2254_7d6f0d9a-05d2-4e93-a94e-6ef7cc11563a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA217272
- Marketing category
- ANDA
- Marketing start
- 2023-03-21
- 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 |
|---|
| 71335-2254-1 | nitrofurantoin macrocrystals | 28 in 1 BOTTLE | CAPSULE | 28 | | 100 |
| 71335-2254-2 | nitrofurantoin macrocrystals | 40 in 1 BOTTLE | CAPSULE | 40 | | 100 |
| 71335-2254-3 | nitrofurantoin macrocrystals | 20 in 1 BOTTLE | CAPSULE | 20 | | 100 |
| 71335-2254-4 | nitrofurantoin macrocrystals | 90 in 1 BOTTLE | CAPSULE | 90 | | 100 |
| 71335-2254-5 | nitrofurantoin macrocrystals | 30 in 1 BOTTLE | CAPSULE | 30 | | 100 |
| 71335-2254-6 | nitrofurantoin macrocrystals | 12 in 1 BOTTLE | CAPSULE | 12 | | 100 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2254 | NITROFURANTOIN MACROCRYSTALS CAPSULE [BRYANT RANCH PREPACK] | 100 | Current NDC, 6 package rows | 20231004_af291b9c-d1b4-42c3-a1e9-bdf3b63fd7e6.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 |
|---|
| 71335-2254-1 | 71335225401 | 28 CAPSULE in 1 BOTTLE (71335-2254-1) | 28 capsule | 2023-10-02 | No | No | Historical |
| 71335-2254-2 | 71335225402 | 40 CAPSULE in 1 BOTTLE (71335-2254-2) | 40 capsule | 2023-10-02 | No | No | Historical |
| 71335-2254-3 | 71335225403 | 20 CAPSULE in 1 BOTTLE (71335-2254-3) | 20 capsule | 2023-10-02 | No | No | Historical |
| 71335-2254-4 | 71335225404 | 90 CAPSULE in 1 BOTTLE (71335-2254-4) | 90 capsule | 2023-10-02 | No | No | Historical |
| 71335-2254-5 | 71335225405 | 30 CAPSULE in 1 BOTTLE (71335-2254-5) | 30 capsule | 2023-10-02 | No | No | Historical |
| 71335-2254-6 | 71335225406 | 12 CAPSULE in 1 BOTTLE (71335-2254-6) | 12 capsule | 2023-10-02 | No | No | Historical |