Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 63629-1748
- 11-digit product format
- 636291748
- Labeler code
- 63629
- Product ID
- 63629-1748_2b80e248-f12d-44f1-aa6d-c4548efda3d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 63629-1748-0 | Nitrofurantoin (monohydrate/macrocrystals) | 6 in 1 BOTTLE | CAPSULE | 6 | | 20 |
| 63629-1748-1 | Nitrofurantoin (monohydrate/macrocrystals) | 20 in 1 BOTTLE | CAPSULE | 20 | | 20 |
| 63629-1748-2 | Nitrofurantoin (monohydrate/macrocrystals) | 14 in 1 BOTTLE | CAPSULE | 14 | | 20 |
| 63629-1748-3 | Nitrofurantoin (monohydrate/macrocrystals) | 30 in 1 BOTTLE | CAPSULE | 30 | | 20 |
| 63629-1748-4 | Nitrofurantoin (monohydrate/macrocrystals) | 28 in 1 BOTTLE | CAPSULE | 28 | | 20 |
| 63629-1748-5 | Nitrofurantoin (monohydrate/macrocrystals) | 60 in 1 BOTTLE | CAPSULE | 60 | | 20 |
| 63629-1748-6 | Nitrofurantoin (monohydrate/macrocrystals) | 10 in 1 BOTTLE | CAPSULE | 10 | | 20 |
| 63629-1748-7 | Nitrofurantoin (monohydrate/macrocrystals) | 90 in 1 BOTTLE | CAPSULE | 90 | | 20 |
| 63629-1748-8 | Nitrofurantoin (monohydrate/macrocrystals) | 21 in 1 BOTTLE | CAPSULE | 21 | | 20 |
| 63629-1748-9 | Nitrofurantoin (monohydrate/macrocrystals) | 8 in 1 BOTTLE | CAPSULE | 8 | | 20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-1748 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [BRYANT RANCH PREPACK] | 20 | Current NDC, Legacy NDC, 10 package rows | 20231110_05f4b126-0fb9-5ee9-c89c-f229e60f84e3.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 |
|---|
| 63629-1748-0 | 63629174800 | 6 CAPSULE in 1 BOTTLE (63629-1748-0) | 6 capsule | 2020-01-08 | 0000-00-00 | No | No | Current |
| 63629-1748-1 | 63629174801 | 20 CAPSULE in 1 BOTTLE (63629-1748-1) | 20 capsule | 2021-12-21 | 0000-00-00 | No | No | Current |
| 63629-1748-2 | 63629174802 | 14 CAPSULE in 1 BOTTLE (63629-1748-2) | 14 capsule | 2007-12-17 | 0000-00-00 | No | No | Current |
| 63629-1748-3 | 63629174803 | 30 CAPSULE in 1 BOTTLE (63629-1748-3) | 30 capsule | 2008-12-16 | 0000-00-00 | No | No | Current |
| 63629-1748-4 | 63629174804 | 28 CAPSULE in 1 BOTTLE (63629-1748-4) | 28 capsule | 2010-07-13 | 0000-00-00 | No | No | Current |
| 63629-1748-5 | 63629174805 | 60 CAPSULE in 1 BOTTLE (63629-1748-5) | 60 capsule | 2021-12-21 | 0000-00-00 | No | No | Current |
| 63629-1748-6 | 63629174806 | 10 CAPSULE in 1 BOTTLE (63629-1748-6) | 10 capsule | 2015-01-21 | 0000-00-00 | No | No | Current |
| 63629-1748-7 | 63629174807 | 90 CAPSULE in 1 BOTTLE (63629-1748-7) | 90 capsule | 2015-05-19 | 0000-00-00 | No | No | Current |
| 63629-1748-8 | 63629174808 | 21 CAPSULE in 1 BOTTLE (63629-1748-8) | 21 capsule | 2021-12-21 | 0000-00-00 | No | No | Current |
| 63629-1748-9 | 63629174809 | 8 CAPSULE in 1 BOTTLE (63629-1748-9) | 8 capsule | 2021-12-21 | 0000-00-00 | No | No | Current |