Nitrofurantoin macrocrystals
- Product NDC
- 43386-641
- 11-digit product format
- 433860641
- Labeler code
- 43386
- Product ID
- 43386-641_2e7ec48f-d605-4e97-8620-299e5f143026
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA203233
- Marketing category
- ANDA
- Marketing start
- 2018-07-09
- 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 |
|---|
| 43386-641-01 | Nitrofurantoin macrocrystals | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
| 43386-641-10 | Nitrofurantoin macrocrystals | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-641 | NITROFURANTOIN MACROCRYSTALS CAPSULE [LUPIN PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240131_52168b36-4e95-4d5b-82be-bbb91c7dcb90.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 |
|---|
| 43386-641-01 | 43386064101 | 100 CAPSULE in 1 BOTTLE (43386-641-01) | 100 capsule | 2018-07-09 | 0000-00-00 | No | No | Current |
| 43386-641-10 | 43386064110 | 1000 CAPSULE in 1 BOTTLE (43386-641-10) | 1000 capsule | 2018-07-09 | 0000-00-00 | No | No | Current |