LEVOLEUCOVORIN CALCIUM
- Product NDC
- 14335-340
- 11-digit product format
- 143350340
- Labeler code
- 14335
- Product ID
- 14335-340_fcf83646-5cb1-2844-e053-6294a90a8a92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levoleucovorin injection
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hainan Poly Pharm. Co., Ltd.
- Application
- ANDA217314
- Marketing category
- ANDA
- Marketing start
- 2023-05-31
- Substance
- LEVOLEUCOVORIN CALCIUM
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Folate Analog [EPC], Folic Acid [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEVOLEUCOVORIN CALCIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOLEUCOVORIN CALCIUM | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 778XL6VBS8 |
| Rxcui | 1720765, 1720773 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 14335-340-01 | LEVOLEUCOVORIN CALCIUM | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 14335-340-01 | LEVOLEUCOVORIN CALCIUM | 17.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 17.5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14335-340 | LEVOLEUCOVORIN CALCIUM (LEVOLEUCOVORIN INJECTION) INJECTION, SOLUTION [HAINAN POLY PHARM. CO., LTD.] | 1 | Current NDC, 2 package rows | 20230601_c10b0c18-dd7c-4a76-a79b-b8d38a08ab87.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 14335-340-01 | 14335034001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (14335-340-01) / 17.5 mL in 1 VIAL, SINGLE-DOSE | 2023-05-31 | No | No | Historical |