nitrofurantoin macrocrystals
- Product NDC
- 68001-603
- 11-digit product format
- 680010603
- Labeler code
- 68001
- Product ID
- 68001-603_471a5d83-5cd5-cebe-e063-6394a90a16ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA217272
- Marketing category
- ANDA
- Marketing start
- 2023-10-11
- Substance
- NITROFURANTOIN
- Active strength
- 25 mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], 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 macrocrystals
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 311994, 311995, 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68001-603-00 | nitrofurantoin macrocrystals | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-603 | NITROFURANTOIN MACROCRYSTALS CAPSULE [BLUEPOINT LABORATORIES] | 2 | Current NDC, 1 package rows | 20231107_cfa20cfd-478f-48c6-9b59-3c425abd766a.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 |
|---|
| 68001-603-00 | 68001060300 | 100 CAPSULE in 1 BOTTLE (68001-603-00) | 100 capsule | 2023-10-11 | No | No | Historical |