Cyanocobalamin
- Product NDC
- 0517-0031
- 11-digit product format
- 005170031
- Labeler code
- 0517
- Product ID
- 0517-0031_28421ba1-7e37-429c-9c66-62cc36f5847c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyanocobalamin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- American Regent, Inc.
- Application
- ANDA080737
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- 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 |
|---|
| 0517-0031-01 | Cyanocobalamin | 1 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 1 | | 12 |
| 0517-0031-25 | Cyanocobalamin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 5 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 5 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 5 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | CYANOCOBALAMIN INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | CYANOCOBALAMIN INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CYANOCOBALAMIN INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CYANOCOBALAMIN INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-0031 | CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20231101_2fb653d6-e2b2-4969-831b-c0dc37b9c0cc.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 |
|---|
| 0517-0031-01 | 00517003101 | 1 mL in 1 VIAL, MULTI-DOSE | 1 ml | | | | | Historical |
| 0517-0031-25 | 00517003125 | 25 VIAL, MULTI-DOSE in 1 TRAY (0517-0031-25) / 1 mL in 1 VIAL, MULTI-DOSE (0517-0031-01) | | 1990-09-30 | 0000-00-00 | No | No | Current |