Cyanocobalamin
- Product NDC
- 0143-9621
- 11-digit product format
- 001439621
- Labeler code
- 0143
- Product ID
- 0143-9621_58925d4c-edff-43c6-9c9b-07102e84e41f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cyanocobalamin
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA080515
- Marketing category
- ANDA
- Marketing start
- 1971-10-20
- Substance
- CYANOCOBALAMIN
- Active strength
- 1000 ug/mL
- Pharmacologic classes
- Vitamin B 12 [CS], Vitamin B12 [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cyanocobalamin
- Listing expiration
- 2027-12-31
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 |
|---|
| 0143-9621-01 | Cyanocobalamin | 1 mL in 1 VIAL | INJECTION | 1 | | 10 |
| 0143-9621-25 | Cyanocobalamin | 25 in 1 BOX | INJECTION | 25 | | 10 |
| 0143-9621-01 | Vitamin Deficiency Injectable System - B12 | 1 mL in 1 VIAL | INJECTION | 1 mL | 1000 ug in 1mL | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9621 | CYANOCOBALAMIN INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240424_a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6.zip |
| 0143-9621 | VITAMIN DEFICIENCY INJECTABLE SYSTEM - B12 (CYANOCOBALAMIN) KIT [IT3 MEDICAL LLC] | 4 | Current NDC, Legacy NDC | 20220302_579bd1fe-51a1-403f-a422-0fb701aab57d.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 |
|---|
| 0143-9621-01 | 00143962101 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 0143-9621-25 | 00143962125 | 25 VIAL in 1 BOX (0143-9621-25) / 1 mL in 1 VIAL (0143-9621-01) | 25 vial | 1971-10-20 | 0000-00-00 | No | No | Current |