cyanocobalamin
- Product NDC
- 68083-562
- 11-digit product format
- 680830562
- Labeler code
- 68083
- Product ID
- 68083-562_771cf601-8f92-4e4f-a29f-b18e71b1ba96
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyanocobalamin
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA214390
- Marketing category
- ANDA
- Marketing start
- 2022-10-14
- Substance
- CYANOCOBALAMIN
- Active strength
- 1000 ug/mL
- Pharmacologic classes
- Vitamin B 12 [CS], Vitamin B12 [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- cyanocobalamin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CYANOCOBALAMIN | 1000 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P6YC3EG204 |
| Rxcui | 309594 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-562-01 | cyanocobalamin | 1 in 1 CARTON | INJECTION | 1 | | 5 |
| 68083-562-01 | cyanocobalamin | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-562 | CYANOCOBALAMIN INJECTION CYANOCOBALAMIN INJECTION [GLAND PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20221104_cd8d188a-fa5d-4580-bcb1-ac8617118cbb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-562-01 | 68083056201 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-562-01) / 30 mL in 1 VIAL, MULTI-DOSE | 2022-10-14 | 0000-00-00 | No | No | Current |