Nitrofurantoin Monohydrate/ Macrocrystalline
- Product NDC
- 63187-263
- 11-digit product format
- 631870263
- Labeler code
- 63187
- Product ID
- 63187-263_46ff38b8-3cbb-4e18-b66f-703b572a37f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Monohydrate/Macrocrystalline
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- NDA020064
- Marketing category
- NDA
- Marketing start
- 2011-05-25
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nitrofurantoin Monohydrate/ Macrocrystalline
- Listing expiration
- 2026-12-31
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 |
|---|
| 63187-263-10 | Nitrofurantoin Monohydrate/ Macrocrystalline | 10 in 1 BOTTLE | CAPSULE | 10 | | 6 |
| 63187-263-14 | Nitrofurantoin Monohydrate/ Macrocrystalline | 14 in 1 BOTTLE | CAPSULE | 14 | | 6 |
| 63187-263-28 | Nitrofurantoin Monohydrate/ Macrocrystalline | 28 in 1 BOTTLE | CAPSULE | 28 | | 6 |
| 63187-263-30 | Nitrofurantoin Monohydrate/ Macrocrystalline | 30 in 1 BOTTLE | CAPSULE | 30 | | 6 |
| 63187-263-60 | Nitrofurantoin Monohydrate/ Macrocrystalline | 60 in 1 BOTTLE | CAPSULE | 60 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-263 | NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE) CAPSULE [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 5 package rows | 20221020_22061f76-2c05-4501-b8dd-a5c372abe7c2.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 |
|---|
| 63187-263-10 | 63187026310 | 10 CAPSULE in 1 BOTTLE (63187-263-10) | 10 capsule | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-263-14 | 63187026314 | 14 CAPSULE in 1 BOTTLE (63187-263-14) | 14 capsule | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-263-28 | 63187026328 | 28 CAPSULE in 1 BOTTLE (63187-263-28) | 28 capsule | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-263-30 | 63187026330 | 30 CAPSULE in 1 BOTTLE (63187-263-30) | 30 capsule | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-263-60 | 63187026360 | 60 CAPSULE in 1 BOTTLE (63187-263-60) | 60 capsule | 2018-11-01 | 0000-00-00 | No | No | Current |