Nitrofurantoin Monohydrate/ Macrocrystalline
- Product NDC
- 70518-0265
- 11-digit product format
- 705180265
- Labeler code
- 70518
- Product ID
- 70518-0265_4e797ba8-c3db-0bd1-e063-6394a90a4f06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Monohydrate/Macrocrystalline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA020064
- Marketing category
- NDA
- Marketing start
- 2017-02-28
- 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/ Macrocrystalline
- 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 |
|---|
| 70518-0265-0 | Nitrofurantoin Monohydrate/ Macrocrystalline | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 25 |
| 70518-0265-1 | Nitrofurantoin Monohydrate/ Macrocrystalline | 14 in 1 BOTTLE, PLASTIC | CAPSULE | 14 | | 25 |
| 70518-0265-2 | Nitrofurantoin Monohydrate/ Macrocrystalline | 14 in 1 BLISTER PACK | CAPSULE | 14 | | 25 |
| 70518-0265-3 | Nitrofurantoin Monohydrate/ Macrocrystalline | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-0265 | NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [REMEDYREPACK INC.] | 22 | Current NDC, Legacy NDC, 4 package rows | 20250425_a4afd48b-003f-4ffa-9ca0-9432b8b0e22b.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 |
|---|
| 70518-0265-0 | 70518026500 | 30 CAPSULE in 1 BLISTER PACK (70518-0265-0) | 30 capsule | 2017-02-28 | 0000-00-00 | No | No | Current |
| 70518-0265-1 | 70518026501 | 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-0265-1) | 14 capsule | 2017-04-14 | 0000-00-00 | No | No | Current |
| 70518-0265-2 | 70518026502 | 14 CAPSULE in 1 BLISTER PACK (70518-0265-2) | 14 capsule | 2019-04-15 | 0000-00-00 | No | No | Current |
| 70518-0265-3 | 70518026503 | 10 CAPSULE in 1 BOTTLE, PLASTIC (70518-0265-3) | 10 capsule | 2019-09-12 | 0000-00-00 | No | No | Current |