FDA.reportPublic FDA data

VITAMIN B12 INJECTION 3000 mcg

Manufacturer
Aspen Veterinary Resources, Ltd
Effective date
2018-02-22
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:40:11

Label at a glance#

ProductVITA-JEC B12 3000
Active ingredientCYANOCOBALAMIN
Label structure5 sections

Dosage and administration

Inject subcutaneously or intramuscularly. May be injected intravenously at the discretion of the veterinarian. Cattle, Horses, Swine and Sheep --1 to 2 mL. Dogs and Cats --0.25 to 0.5 mL. Suggested dosage may be repeated at 1 to 2 week intervals, as indicated by condition and response. TAKE TIME OBSERVE LABEL DIRECTIONS

Storage and handling

Store between 15 o  and 30 o C (59 o - 86 o F). Avoid exposure to light.

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

3000 mcg Injection

For Animal Use Only

Keep Out Of Reach Of Children

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

INDICATIONS

For use as a supplemental nutritive source of vitamin B12 in cattle, horses, swine, sheep, dogs and cats.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Inject subcutaneously or intramuscularly. May be injected intravenously at the discretion of the veterinarian.

Cattle, Horses, Swine and Sheep--1 to 2 mL.
Dogs and Cats--0.25 to 0.5 mL.

Suggested dosage may be repeated at 1 to 2 week intervals, as indicated by condition and response.

TAKE TIME OBSERVE LABEL DIRECTIONS

COMPOSITION

DOSAGE FORMS & STRENGTHS SECTION

Each mL of sterile aqueous solution contains: 
Cyanocobalamin (B12) 3000 mcg with sodium chloride 0.22% w/v, ammonium sulfate 0.1% w/v, citric acid 0.01% w/v, sodium citrate 0.008% w/v, and banzyl alchohol 1.0% v/v  (preservative).

STORAGE

STORAGE AND HANDLING SECTION

Store between 15o and 30oC (59o - 86oF).

Avoid exposure to light.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AS-VitaJec B12 3XAS-VitaJec B12 3XAS-VitaJec B12 3XAS-VitaJec B12 3X

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1006047vitamin B-12 3000 MCG in 1 ML Injectable SolutionPSN4
1006047vitamin B12 3 MG/ML Injectable SolutionSCD4
1006047cyanocobalamin 3 MG/ML Injectable SolutionSY4
1006047cyanocobalamin 3000 MCG per 1 ML Injectable SolutionSY4
1006047cyanocobalamin 3000 MCG/ML Injectable SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130099355004627GTIN-13: 0099355004627
EAN-13: 0099355004627
GTIN-12: 099355004627
UPC-A: 099355004627
GTIN storage (14 digits): 00099355004627		AS-VitaJec B12 3X-18.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46066-226-04VITA-JEC B12 3000100 mL in 1 VIALINJECTION1004
46066-226-05VITA-JEC B12 3000250 mL in 1 VIALINJECTION2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46066-226VITA-JEC B12 3000 (CYANOCOBALAMIN) INJECTION [ASPEN VETERINARY RESOURCES, LTD]42 package rows20180222_8f296c93-a91f-4a0f-a7ed-365be4b76ad3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46066-22646066-226-04, 46066-226-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYANOCOBALAMINP6YC3EG204ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst54f088b1-7cf8-3837-e063-6294a90a88e72026-09-02Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINLifestar Pharma LLCb1e35c97-2157-454e-967f-53a4300827de2026-08-06Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINNorthStar RxLLCce0183b3-4410-466a-b57d-cd360d461b7c2026-08-06Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
Non-proprietary nameCYANOCOBALAMINXseer Pharmaceuticals3bb870d8-128d-75ea-e063-6394a90a707b2026-05-13Name fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINPlano Pharmaceuticals Inc.4cbc05f6-4b31-4a5f-e063-6394a90a676c2026-03-25Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
cyanocobalaminCYANOCOBALAMINSportpharm LLC647842f4-b211-4f52-8b73-975fae7670232026-02-05Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINA-S Medication Solutionsa61181f5-7e2d-45f9-929a-cb8bc70c992e2026-01-06Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINSOLA Pharmaceuticalse559c6c8-2973-77fb-e053-2995a90af43d2025-12-08Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINBluePoint Laboratories5c603ad0-9023-44cc-955c-3988d5dcf0d32025-12-05Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CYANOCOBALAMINCYANOCOBALAMINHenry Schein, Inc.ff32f34b-89b3-4617-ad42-2e8bcb88627e2025-10-16Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINHenry Schein, Inc.92f08572-cfd9-4a99-bb49-937ab94eeb622025-09-10Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
cyanocobalaminCYANOCOBALAMINSomerset Therapeutics, LLC41ac0dc1-0a71-4c69-8e25-ba838f5f16a32025-09-04Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CYANOCOBALAMINCYANOCOBALAMINSomerset Therapeutics, LLC617e44f8-df80-4764-85b9-be0fb6da8db32025-08-29Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.064c6841-3ed2-417f-a77c-a730785b60362025-06-12Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirst9d4ac337-5f4d-ef47-e053-2a95a90a6dbf2025-01-08Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINVitruvias Therapeutics2117af8a-723f-4e2f-98a6-83ad2c4237512024-12-20Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLCacff4ff3-4435-4995-a117-dbfcdf72334a2024-12-15Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINFresenius Kabi USA, LLC8b1cdee5-3368-40e4-90bf-31a64df1f38a2024-12-12Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.9c37fd25-2143-410c-8d89-d39aa5c7b4532024-11-22Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN
CyanocobalaminCYANOCOBALAMINMeitheal Pharmaceuticals Inc.c6436212-9246-4e29-8540-9af992b667eb2024-06-03Warnings, Adverse reactionsName fallback
generic name: CYANOCOBALAMIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.