Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 70518-1087
- 11-digit product format
- 705181087
- Labeler code
- 70518
- Product ID
- 70518-1087_4859ae78-70e1-f5a3-e063-6394a90a2d24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077066
- Marketing category
- ANDA
- Marketing start
- 2018-03-29
- 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 |
|---|
| 70518-1087-0 | Nitrofurantoin (monohydrate/macrocrystals) | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | | 17 |
| 70518-1087-1 | Nitrofurantoin (monohydrate/macrocrystals) | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 17 |
| 70518-1087-2 | Nitrofurantoin (monohydrate/macrocrystals) | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 17 |
| 70518-1087-3 | Nitrofurantoin (monohydrate/macrocrystals) | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-1087 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [REMEDYREPACK INC.] | 15 | Current NDC, Legacy NDC, 4 package rows | 20250507_ae892973-9ef4-4cf0-baf3-fbe158697bac.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 |
|---|
| 70518-1087-0 | 70518108700 | 14 in 1 BOTTLE, PLASTIC | | | | | | Historical |
| 70518-1087-1 | 70518108701 | 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-1087-1) | 10 capsule | 2018-08-16 | | No | No | Current |
| 70518-1087-2 | 70518108702 | 30 CAPSULE in 1 BLISTER PACK (70518-1087-2) | 30 capsule | 2021-10-11 | 0000-00-00 | No | No | Current |
| 70518-1087-3 | 70518108703 | 28 CAPSULE in 1 BOTTLE, PLASTIC (70518-1087-3) | 28 capsule | 2022-03-30 | 0000-00-00 | No | No | Current |