nitrofurantoin macrocrystals
- Product NDC
- 83939-0016
- 11-digit product format
- 839390016
- Labeler code
- 83939
- Product ID
- 83939-0016_42a1c7bc-b4e0-7570-e063-6294a90aec99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nitrofurantoin macrocrystals
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- VERITYRX, LLC
- Application
- ANDA217272
- Marketing category
- ANDA
- Marketing start
- 2023-03-21
- Substance
- NITROFURANTOIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- Nitrofuran Antibacterial [EPC], 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 macrocrystals
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 1648759 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83939-0016-1 | nitrofurantoin macrocrystals | 1 in 1 POUCH | CAPSULE | 1 | | 1 |
| 83939-0016-2 | nitrofurantoin macrocrystals | 1 in 1 POUCH | CAPSULE | 1 | | 1 |
| 83939-0016-2 | nitrofurantoin macrocrystals | 50 in 1 BOX, UNIT-DOSE | CAPSULE | 50 | | 1 |
| 83939-0016-3 | nitrofurantoin macrocrystals | 1 in 1 POUCH | CAPSULE | 1 | | 1 |
| 83939-0016-3 | nitrofurantoin macrocrystals | 100 in 1 BOX, UNIT-DOSE | CAPSULE | 100 | | 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 |
|---|
| 83939-0016-1 | 83939001601 | 1 CAPSULE in 1 POUCH (83939-0016-1) | 1 capsule | 2025-11-10 | No | No | Historical |
| 83939-0016-2 | 83939001602 | 50 POUCH in 1 BOX, UNIT-DOSE (83939-0016-2) / 1 CAPSULE in 1 POUCH | 50 pouch | 2025-11-10 | No | No | Historical |
| 83939-0016-3 | 83939001603 | 100 POUCH in 1 BOX, UNIT-DOSE (83939-0016-3) / 1 CAPSULE in 1 POUCH | 100 pouch | 2025-11-10 | No | No | Historical |