Nitrofurantoin Mono
- Product NDC
- 54348-849
- 11-digit product format
- 543480849
- Labeler code
- 54348
- Product ID
- 54348-849_eaa5e1eb-d68d-a3f7-e053-2995a90aa735
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NITROFURANTOIN MONOHYDRATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- NDA020064
- Marketing category
- NDA
- Marketing start
- 2019-07-10
- 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 Mono
- 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 |
|---|
| 54348-849-06 | Nitrofurantoin Mono | 6 in 1 BOTTLE | CAPSULE | 6 | | 2 |
| 54348-849-06 | Nitrofurantoin Mono | 1 in 1 BOX | CAPSULE | 1 | | 2 |
| 54348-849-10 | Nitrofurantoin Mono | 1 in 1 BOX | CAPSULE | 1 | | 2 |
| 54348-849-10 | Nitrofurantoin Mono | 10 in 1 BOTTLE | CAPSULE | 10 | | 2 |
| 54348-849-14 | Nitrofurantoin Mono | 1 in 1 BOX | CAPSULE | 1 | | 2 |
| 54348-849-14 | Nitrofurantoin Mono | 14 in 1 BOTTLE | CAPSULE | 14 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54348-849 | NITROFURANTOIN MONO (NITROFURANTOIN MONOHYDRATE) CAPSULE [PHARMPAK, INC.] | 2 | Current NDC, Legacy NDC, 6 package rows | 20221011_d9840719-271f-42a9-a5c9-3e039ec8fbac.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 |
|---|
| 54348-849-06 | 54348084906 | 1 BOTTLE in 1 BOX (54348-849-06) / 6 CAPSULE in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |
| 54348-849-10 | 54348084910 | 1 BOTTLE in 1 BOX (54348-849-10) / 10 CAPSULE in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |
| 54348-849-14 | 54348084914 | 1 BOTTLE in 1 BOX (54348-849-14) / 14 CAPSULE in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |