Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 63187-995
- 11-digit product format
- 631870995
- Labeler code
- 63187
- Product ID
- 63187-995_ae7e968c-c9fd-48ec-b93b-72ff585d6e65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077066
- Marketing category
- ANDA
- Marketing start
- 2005-04-06
- 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/macrocrystals)
- 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 |
|---|
| 63187-995-10 | Nitrofurantoin (monohydrate/macrocrystals) | 10 in 1 BOTTLE | CAPSULE | 10 | | 4 |
| 63187-995-14 | Nitrofurantoin (monohydrate/macrocrystals) | 14 in 1 BOTTLE | CAPSULE | 14 | | 4 |
| 63187-995-20 | Nitrofurantoin (monohydrate/macrocrystals) | 20 in 1 BOTTLE | CAPSULE | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-995 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 3 package rows | 20221001_d802d734-dc8f-4f3c-bce6-aaccc4614c89.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 |
|---|
| 63187-995-10 | 63187099510 | 10 CAPSULE in 1 BOTTLE (63187-995-10) | 10 capsule | 2018-03-01 | 0000-00-00 | No | No | Current |
| 63187-995-14 | 63187099514 | 14 CAPSULE in 1 BOTTLE (63187-995-14) | 14 capsule | 2018-03-01 | 0000-00-00 | No | No | Current |
| 63187-995-20 | 63187099520 | 20 CAPSULE in 1 BOTTLE (63187-995-20) | 20 capsule | 2018-03-01 | 0000-00-00 | No | No | Current |