Cyanocobalamin
- Product NDC
- 63323-044
- 11-digit product format
- 633230044
- Labeler code
- 63323
- Product ID
- 63323-044_0a2dc386-15b3-45a3-91d7-80b9cf202c03
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CYANOCOBALAMIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA080557
- Marketing category
- ANDA
- Marketing start
- 2000-10-18
- 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 |
|---|
| 63323-044-00 | Physicians EZ Use B-12 Compliance | 1 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 1 mL | 1000 ug in 1mL | 6 |
| 63323-044-00 | Cyanocobalamin | 1 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 1 | | 4 |
| 63323-044-01 | Cyanocobalamin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 4 |
| 63323-044-41 | Cyanocobalamin | 1 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 1 | | 3 |
| 63323-044-44 | Cyanocobalamin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| Isopropyl Alcohol | ACTIVE INGREDIENT | ND2M416302 | PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] | 1 | |
| Cyanocobalamin | ACTIVE MOIETY | P6YC3EG204 | PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| Isopropyl Alcohol | ACTIVE MOIETY | ND2M416302 | PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | CYANOCOBALAMIN INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PHYSICIANS EZ USE B-12 COMPLIANCE KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM MANUFACTURING
] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-044 | PHYSICIANS EZ USE B-12 COMPLIANCE KIT [ASCLEMED USA, INC.] | 6 | Current NDC, Legacy NDC | 20241008_168f94ea-2faf-4aeb-88a5-8753ad60a1c4.zip |
| 63323-044 | CYANOCOBALAMIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250123_acff4ff3-4435-4995-a117-dbfcdf72334a.zip |
| 63323-044 | CYANOCOBALAMIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241220_8b1cdee5-3368-40e4-90bf-31a64df1f38a.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 |
|---|
| 63323-044-00 | 63323004400 | 1 mL in 1 VIAL, MULTI-DOSE | 1 ml | | | | | Historical |
| 63323-044-01 | 63323004401 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-00) | | 2000-10-18 | 0000-00-00 | No | No | Current |
| 63323-044-41 | 63323004441 | 1 mL in 1 VIAL, MULTI-DOSE | 1 ml | | | | | Historical |
| 63323-044-44 | 63323004444 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-44) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-41) | | 2000-10-18 | 0000-00-00 | No | No | Current |