Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 71335-2377
- 11-digit product format
- 713352377
- Labeler code
- 71335
- Product ID
- 71335-2377_140ec378-126e-409d-8cbd-46f9e343a9ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA217357
- Marketing category
- ANDA
- Marketing start
- 2023-09-14
- 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 |
|---|
| 71335-2377-0 | Nitrofurantoin (monohydrate/macrocrystals) | 6 in 1 BOTTLE | CAPSULE | 6 | | 3 |
| 71335-2377-1 | Nitrofurantoin (monohydrate/macrocrystals) | 20 in 1 BOTTLE | CAPSULE | 20 | | 3 |
| 71335-2377-2 | Nitrofurantoin (monohydrate/macrocrystals) | 14 in 1 BOTTLE | CAPSULE | 14 | | 3 |
| 71335-2377-3 | Nitrofurantoin (monohydrate/macrocrystals) | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
| 71335-2377-4 | Nitrofurantoin (monohydrate/macrocrystals) | 28 in 1 BOTTLE | CAPSULE | 28 | | 3 |
| 71335-2377-5 | Nitrofurantoin (monohydrate/macrocrystals) | 60 in 1 BOTTLE | CAPSULE | 60 | | 3 |
| 71335-2377-6 | Nitrofurantoin (monohydrate/macrocrystals) | 10 in 1 BOTTLE | CAPSULE | 10 | | 3 |
| 71335-2377-7 | Nitrofurantoin (monohydrate/macrocrystals) | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
| 71335-2377-8 | Nitrofurantoin (monohydrate/macrocrystals) | 21 in 1 BOTTLE | CAPSULE | 21 | | 3 |
| 71335-2377-9 | Nitrofurantoin (monohydrate/macrocrystals) | 8 in 1 BOTTLE | CAPSULE | 8 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2377 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [BRYANT RANCH PREPACK] | 3 | Current NDC, 10 package rows | 20250412_63a4b367-bf4b-4b5f-b3e9-394ba307886d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2377-0 | 71335237700 | 6 CAPSULE in 1 BOTTLE (71335-2377-0) | 6 capsule | 2024-05-29 | No | No | Historical |
| 71335-2377-1 | 71335237701 | 20 CAPSULE in 1 BOTTLE (71335-2377-1) | 20 capsule | 2024-05-29 | No | No | Historical |
| 71335-2377-2 | 71335237702 | 14 CAPSULE in 1 BOTTLE (71335-2377-2) | 14 capsule | 2024-05-29 | No | No | Historical |
| 71335-2377-3 | 71335237703 | 30 CAPSULE in 1 BOTTLE (71335-2377-3) | 30 capsule | 2024-05-29 | No | No | Historical |
| 71335-2377-4 | 71335237704 | 28 CAPSULE in 1 BOTTLE (71335-2377-4) | 28 capsule | 2024-05-29 | No | No | Historical |
| 71335-2377-5 | 71335237705 | 60 CAPSULE in 1 BOTTLE (71335-2377-5) | 60 capsule | 2024-05-29 | No | No | Historical |
| 71335-2377-6 | 71335237706 | 10 CAPSULE in 1 BOTTLE (71335-2377-6) | 10 capsule | 2024-05-29 | No | No | Historical |
| 71335-2377-7 | 71335237707 | 90 CAPSULE in 1 BOTTLE (71335-2377-7) | 90 capsule | 2024-05-29 | No | No | Historical |
| 71335-2377-8 | 71335237708 | 21 CAPSULE in 1 BOTTLE (71335-2377-8) | 21 capsule | 2024-05-29 | No | No | Historical |
| 71335-2377-9 | 71335237709 | 8 CAPSULE in 1 BOTTLE (71335-2377-9) | 8 capsule | 2024-05-29 | No | No | Historical |