nitrofurantoin macrocrystals
- Product NDC
- 70518-3827
- 11-digit product format
- 705183827
- Labeler code
- 70518
- Product ID
- 70518-3827_3f66ecaf-4520-5734-e063-6294a90aecaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA217272
- Marketing category
- ANDA
- Marketing start
- 2023-08-12
- Substance
- NITROFURANTOIN
- Active strength
- 100 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3827-0 | nitrofurantoin macrocrystals | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | | 6 |
| 70518-3827-1 | nitrofurantoin macrocrystals | 6 in 1 BOTTLE, PLASTIC | CAPSULE | 6 | | 6 |
| 70518-3827-2 | nitrofurantoin macrocrystals | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3827 | NITROFURANTOIN MACROCRYSTALS CAPSULE [REMEDYREPACK INC.] | 5 | Current NDC, 3 package rows | 20250209_27f2ed1a-d4c2-4c12-92a6-3d0e9ce7f6a1.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 |
|---|
| 70518-3827-0 | 70518382700 | 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-0) | 14 capsule | 2023-08-12 | No | No | Current |
| 70518-3827-1 | 70518382701 | 6 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-1) | 6 capsule | 2025-01-28 | No | No | Current |
| 70518-3827-2 | 70518382702 | 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-3827-2) | 10 capsule | 2025-01-30 | No | No | Current |