Nitrofurantoin Monohydrate/Macrocrystal
- Product NDC
- 72189-395
- 11-digit product format
- 721890395
- Labeler code
- 72189
- Product ID
- 72189-395_1e79886c-8ce2-c6ef-e063-6394a90a7a83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitrofurantoin Monohydrate/Macrocrystal
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA208516
- Marketing category
- ANDA
- Marketing start
- 2022-11-22
- 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/Macrocrystal
- 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 |
|---|
| 72189-395-10 | Nitrofurantoin Monohydrate/Macrocrystal | 10 in 1 BOTTLE | CAPSULE | 10 | | 5 |
| 72189-395-14 | Nitrofurantoin Monohydrate/Macrocrystal | 14 in 1 BOTTLE | CAPSULE | 14 | | 5 |
| 72189-395-20 | Nitrofurantoin Monohydrate/Macrocrystal | 20 in 1 BOTTLE | CAPSULE | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-395 | NITROFURANTOIN MONOHYDRATE/MACROCRYSTAL CAPSULE [DIRECT_RX] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240731_ee13cf2a-cde0-8ab8-e053-2a95a90a9dda.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 |
|---|
| 72189-395-10 | 72189039510 | 10 CAPSULE in 1 BOTTLE (72189-395-10) | 10 capsule | 2022-11-22 | | No | No | Current |
| 72189-395-14 | 72189039514 | 14 CAPSULE in 1 BOTTLE (72189-395-14) | 14 capsule | 2022-11-22 | 0000-00-00 | No | No | Current |
| 72189-395-20 | 72189039520 | 20 CAPSULE in 1 BOTTLE (72189-395-20) | 20 capsule | 2022-11-22 | | No | No | Current |