NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Product NDC
- 82619-147
- 11-digit product format
- 826190147
- Labeler code
- 82619
- Product ID
- 82619-147_4f67eeb9-5a7a-3693-e063-6394a90a8655
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin (monohydrate/macrocrystals)
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Creekwood Pharmaceuticals LLC
- Application
- ANDA220269
- Marketing category
- ANDA
- Marketing start
- 2026-04-20
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Listing expiration
- 2027-12-31
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 |
|---|
| 82619-147-01 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 82619-147-02 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
| 82619-147-03 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 14 in 1 BLISTER PACK | CAPSULE | 14 | | 1 |
| 82619-147-03 | NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | 1 in 1 CARTON | CAPSULE | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82619-147-01 | 82619014701 | 100 CAPSULE in 1 BOTTLE (82619-147-01) | 100 capsule | 2026-04-20 | No | No | Historical |
| 82619-147-02 | 82619014702 | 500 CAPSULE in 1 BOTTLE (82619-147-02) | 500 capsule | 2026-04-20 | No | No | Historical |
| 82619-147-03 | 82619014703 | 1 BLISTER PACK in 1 CARTON (82619-147-03) / 14 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2026-04-20 | No | No | Historical |