MedPath

Cyanocobalamin

Approved
Approval ID

96edc686-afea-47e1-adf2-e3d478125b96

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 1, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

cyanocobalamin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-0762
Application NumberANDA080737
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyanocobalamin
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateJuly 1, 2010
FDA Product Classification

INGREDIENTS (3)

CYANOCOBALAMINActive
Quantity: 1000 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT

Drug Labeling Information

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/1/2010

Rx Only

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/1/2010

DOSAGE AND ADMINISTRATION

Avoid using the intravenous route. Use of this product intravenously will result in almost all of the vitamin being lost in the urine.

Pernicious Anemia: Parenteral vitamin B12 is the recommended treatment and will be required for the remainder of the patient's life. The oral form is not dependable. A dose of 100 mcg daily for 6 or 7 days should be administered by intramuscular or deep subcutaneous injection. If there is clinical improvement and if a reticulocyte response is observed, the same amount may be given on alternate days for seven doses, then every 3 to 4 days for another 2 to 3 weeks. By this time hematologic values should have become normal. This regimen should be followed by 100 mcg monthly for life. Folic acid should be administered concomitantly if needed.

Patients with Normal Intestinal Absorption: Where the oral route is not deemed adequate, initial treatment similar to that for patients with pernicious anemia may be indicated depending on the severity of the deficiency. Chronic treatment should be with an oral B12 preparation. If other vitamin deficiencies are present, they should be treated.

Schilling Test: The flushing dose is 1000 mcg.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 7/1/2010

HOW SUPPLIED

Cyanocobalamin Injection, USP 1000 mcg/mL

NDC 54868-0762-1 1 mL Vial Tray of 25

NDC 54868-0762-0 30 mL Multiple Dose Vial Boxes of 1

NDC 54868-0762-2 30 mL Multiple Dose Vial Boxes of 5

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).

PROTECT THE PRODUCT FROM LIGHT.

IN0031
Rev. 11/05
MG #10565

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Relabeling of "Additional Barcode" by:
Physicians Total Care, Inc.
Tulsa, OK 74146

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Cyanocobalamin - FDA Drug Approval Details