FDA.reportPublic FDA data

B-12 (Cyanocobalamin)

Manufacturer
Nationwide Pharmaceutical LLC
Effective date
2025-02-19
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:51:28

Label at a glance#

ProductB-12 (Cyanocobalamin)
Active ingredientCyanocobalamin
Label structure6 sections

Dosage and administration

Adults 18 years or older: 500 mcg (1 tablet) daily preferably with a meal or as directed by your doctor. Persons under 18 years of age: Consult your doctor.

Label contents#

Full prescribing information#

WARNINGS SECTION

Warning: Do not exceed recommended dosage. Consult your physician before taking this product if you have vascular disease (such as heart disease or history of stroke) or diabetes, are pregnant or nursing, taking medication, facing surgery, have bleeding problems, or undergoing any treatment which may affect the ability of blood to clot.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults 18 years or older: 500 mcg (1 tablet) daily preferably with a meal or as directed by your doctor.

Persons under 18 years of age: Consult your doctor.

Other Information

HEALTH CLAIM SECTION

  • Store in a cool, dry place at controlled room termperature 15-30°C ( 58-86°F)
  • Protect from moisture
  • Store in original container for better identification
  • Use by expiration date on package

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size: 1 Tablet
Amount Per Tablet % Daily Value
Vitamin B-12 (as Cyanocobalamin)500 mcg20,833%
Other Ingredients: Microcrystalline Cellulose 102, Croscarmellose Sodium, Silicon Dioxide, Stearic Acid, Magnesium Stearate

HEALTH CLAIM SECTION

Manufactured for/Distributed by:
Nationwide Pharmaceutical LLC
San Antonio, TX 78216
Rev 1/2025

PRINCIPAL DISPLAY PANEL - 500 mcg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nationwide
Pharmaceutical
NDC 69375-0013-10

B-12

500 mcg

(Cyanocobalamin)

100 TABLETS

Made in the USA

69375-0013-10
69375-0013-10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313896vitamin B 12 500 MCG Oral TabletPSN2
313896vitamin B12 0.5 MG Oral TabletSCD2
313896cyanocobalamin 0.5 MG Oral TabletSY2
313896cyanocobalamin 500 MCG Oral TabletSY2

DailyMed Pharmacologic Classes#

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

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
69375-013-10B-12 (Cyanocobalamin)100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69375-013B-12 (CYANOCOBALAMIN) (CYANOCOBALAMIN) TABLET [NATIONWIDE PHARMACEUTICAL LLC]21 package rows20250226_59cff4a0-da7b-40de-87b5-cf3cd400bbf7.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69375-01369375-013-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CyanocobalaminP6YC3EG204ACTIB
Microcrystalline Cellulose 102PNR0YF693YIACT
Croscarmellose sodiumM28OL1HH48IACT
Silicon DioxideETJ7Z6XBU4IACT
Stearic Acid4ELV7Z65APIACT
Magnesium stearate70097M6I30IACT

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 · 37 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.