Nitrofurantoin (monohydrate/macrocrystals)
- Product NDC
- 42708-178
- 11-digit product format
- 427080178
- Labeler code
- 42708
- Product ID
- 42708-178_4653d906-5cc5-bfd4-e063-6294a90a9b9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- QPharma, Inc.
- 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 |
|---|
| 42708-178-28 | Nitrofurantoin (monohydrate/macrocrystals) | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42708-178 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) CAPSULE [QPHARMA, INC.] | 2 | Current NDC, 1 package rows | 20241123_fbc05ccb-782b-55f6-e053-6394a90a7fd6.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 |
|---|
| 42708-178-28 | 42708017828 | 28 CAPSULE in 1 BOTTLE, PLASTIC (42708-178-28) | 28 capsule | 2023-05-26 | Yes | No | Historical |