nitrofurantoin macrocrystals
- Product NDC
- 68382-559
- 11-digit product format
- 683820559
- Labeler code
- 68382
- Product ID
- 68382-559_0d11f48c-867f-471c-a74c-9d50f6a76cfd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA205005
- Marketing category
- ANDA
- Marketing start
- 2018-02-15
- 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, 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-559-01 | nitrofurantoin macrocrystals | 100 in 1 BOTTLE | CAPSULE | 100 | | 6 |
| 68382-559-10 | nitrofurantoin macrocrystals | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 6 |
| 68382-559-30 | nitrofurantoin macrocrystals | 10 in 1 CARTON | CAPSULE | 10 | | 6 |
| 68382-559-30 | nitrofurantoin macrocrystals | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-559 | NITROFURANTOIN MACROCRYSTALS CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20231122_2862e49a-66e9-4418-9343-4404036775fc.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 |
|---|
| 68382-559-01 | 68382055901 | 100 CAPSULE in 1 BOTTLE (68382-559-01) | 100 capsule | 2018-02-15 | 0000-00-00 | No | No | Current |
| 68382-559-10 | 68382055910 | 1000 CAPSULE in 1 BOTTLE (68382-559-10) | 1000 capsule | 2018-02-15 | 0000-00-00 | No | No | Current |
| 68382-559-30 | 68382055930 | 10 BLISTER PACK in 1 CARTON (68382-559-30) / 10 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2018-02-15 | 0000-00-00 | No | No | Current |