Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 70518-4026
- 11-digit product format
- 705184026
- Labeler code
- 70518
- Product ID
- 70518-4026_507169f8-1c30-a0e1-e063-6294a90ad062
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA217357
- Marketing category
- ANDA
- Marketing start
- 2024-02-21
- Substance
- NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
- Active strength
- 25; 75 mg/1; mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], 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 (monohydrate/macrocrystals)
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 25 mg/1 |
| NITROFURANTOIN MONOHYDRATE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L, E1QI2CQQ1I |
| Rxcui | 1648755 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4026-0 | Nitrofurantoin (monohydrate/macrocrystals) | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 6 |
| 70518-4026-1 | Nitrofurantoin (monohydrate/macrocrystals) | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | | 6 |
| 70518-4026-2 | Nitrofurantoin (monohydrate/macrocrystals) | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 6 |
| 70518-4026-3 | Nitrofurantoin (monohydrate/macrocrystals) | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | | 6 |
| 70518-4026-4 | Nitrofurantoin (monohydrate/macrocrystals) | 50 in 1 BOX | CAPSULE | 50 | | 6 |
| 70518-4026-5 | Nitrofurantoin (monohydrate/macrocrystals) | 1 in 1 POUCH | CAPSULE | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4026 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REMEDYREPACK INC.] | 4 | Current NDC, 6 package rows | 20250328_e55f3dc2-c754-4550-a2c0-c304471a8791.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 |
|---|
| 70518-4026-0 | 70518402600 | 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-0) | 10 capsule | 2024-02-21 | No | No | Historical |
| 70518-4026-1 | 70518402601 | 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-4026-1) | 14 capsule | 2024-02-21 | No | No | Historical |
| 70518-4026-2 | 70518402602 | 30 CAPSULE in 1 BLISTER PACK (70518-4026-2) | 30 capsule | 2024-05-03 | No | No | Historical |
| 70518-4026-3 | 70518402603 | 20 in 1 BOTTLE, PLASTIC | | | | | Historical |
| 70518-4026-4 | 70518402604 | 50 POUCH in 1 BOX (70518-4026-4) / 1 CAPSULE in 1 POUCH (70518-4026-5) | 50 pouch | 2026-04-24 | No | No | Historical |
| 70518-4026-5 | 70518402605 | 1 in 1 POUCH | | | | | Historical |