NITROFURANTOIN
- Product NDC
- 70377-118
- 11-digit product format
- 703770118
- Labeler code
- 70377
- Product ID
- 70377-118_3cd77dd5-7b86-a52f-fa61-69afc7b4c6b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NITROFURANTOIN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Biocon Pharma Inc
- Application
- ANDA218346
- Marketing category
- ANDA
- Marketing start
- 2024-11-15
- Substance
- NITROFURANTOIN
- Active strength
- 25 mg/5mL
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NITROFURANTOIN | 25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 927AH8112L |
| Rxcui | 311989 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70377-118-31 | NITROFURANTOIN | 1 in 1 CARTON | SUSPENSION | 1 | | 2 |
| 70377-118-31 | NITROFURANTOIN | 230 mL in 1 BOTTLE, GLASS | SUSPENSION | 230 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70377-118 | NITROFURANTOIN SUSPENSION [BIOCON PHARMA INC] | 2 | Current NDC, 2 package rows | 20241122_68c718a7-2e8f-288c-37d2-053372ee61b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70377-118-31 | 70377011831 | 1 BOTTLE, GLASS in 1 CARTON (70377-118-31) / 230 mL in 1 BOTTLE, GLASS | 2024-11-15 | No | No | Current |