RIBAVIRIN
- Product NDC
- 68382-395
- 11-digit product format
- 683820395
- Labeler code
- 68382
- Product ID
- 68382-395_5b244567-d037-4fbd-9e2b-ed394e1c07b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ribavirin
- Dosage form
- POWDER, FOR SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA207366
- Marketing category
- ANDA
- Marketing start
- 2016-12-15
- Substance
- RIBAVIRIN
- Active strength
- 6 g/1
- Pharmacologic classes
- Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RIBAVIRIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RIBAVIRIN | 6 g/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 49717AWG6K |
| Rxcui | 312818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-395-04 | RIBAVIRIN | 1 in 1 VIAL | POWDER, FOR SOLUTION | 1 | | 4 |
| 68382-395-04 | RIBAVIRIN | 4 in 1 CARTON | POWDER, FOR SOLUTION | 4 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-395 | RIBAVIRIN POWDER, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20221217_2c3a64d5-fde2-437b-bafc-e76dd187d85a.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 |
|---|
| 68382-395-04 | 68382039504 | 4 VIAL in 1 CARTON (68382-395-04) / 1 POWDER, FOR SOLUTION in 1 VIAL | 4 vial | 2016-12-15 | 0000-00-00 | No | No | Current |