NDC codes

FDA NDC Directory
Product NDC (as listed)68001-542Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0542Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68001-542-60680010542606800105426025 VIAL, MULTI-DOSE in 1 TRAY (68001-542-60) / 1 mL in 1 VIAL, MULTI-DOSE (68001-542-59)Marketed from Jun 24, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Cyanocobalamin
Generic name (nonproprietary)
cyanocobalamin
Active ingredients
Cyanocobalamin — 1000 ug/mL
Dosage form
Injection, Solution
Route
Subcutaneous
Labeler
BluePoint LaboratoriesNDC labeler code 68001
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 080737
Marketing start
Marketing end
Other FDA classes
Vitamin B 12 (Chemical structure)
Identifiers
Product ID 68001-542_5d666fe2-b7ff-562a-e063-6294a90a75fdSPL ID 5d666fe2-b7ff-562a-e063-6294a90a75fd
Pharmacologic class
Vitamin B12

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468001054260 followed by a unit qualifier and the quantity

Package 68001-0542-60. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68001-542

What is NDC 68001-542?
68001-542 is the product NDC for Cyanocobalamin, Cyanocobalamin 1000 ug/mL injection, solution, listed with the FDA by BluePoint Laboratories. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cyanocobalamin.
What is the active ingredient?
Cyanocobalamin.
Who is the labeler?
BluePoint Laboratories, NDC labeler code 68001. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cyanocobalamin?
50 other product NDCs are listed under this name. See all Cyanocobalamin NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cyanocobalamin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscular, SubcutaneousLifestar Pharma LLC70756-63770756-0637-0570756-0637-1070756-0637-88
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscular, SubcutaneousHenry Schein, Inc.0404-978300404-9783-30
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscularHenry Schein, Inc.0404-978600404-9786-10
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscular, SubcutaneousBluePoint Laboratories68001-64068001-0640-60
CyanocobalaminCyanocobalamin 1000 ug/mLInjectionIntramuscular, SubcutaneousMeitheal Pharmaceuticals Inc.71288-30071288-0300-02
CyanocobalaminCyanocobalamin 1000 ug/mLInjectionIntramuscular, SubcutaneousMeitheal Pharmaceuticals Inc.71288-30171288-0301-11
CyanocobalaminCyanocobalamin 1000 ug/mLInjectionIntramuscular, SubcutaneousMeitheal Pharmaceuticals Inc.71288-30271288-0302-30
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscular, SubcutaneousNorthStar RxLLC72603-65072603-0650-25
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscular, SubcutaneousLifestar Pharma LLC70756-63570756-0635-1070756-0635-25
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscular, SubcutaneousLifestar Pharma LLC70756-63670756-0636-1070756-0636-25

All 51 Cyanocobalamin NDCs

Other NDCs under ANDA 080737

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 080737
ProductStrengthForm · routeLabelerProduct NDC
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscular, SubcutaneousAmerican Regent, Inc.0517-0031
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscular, SubcutaneousAmerican Regent, Inc.0517-0032
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscular, SubcutaneousAmerican Regent, Inc.0517-0130
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-1440
CyanocobalaminCyanocobalamin 1000 ug/mLInjection, SolutionIntramuscular, SubcutaneousHF Acquisition Co LLC, DBA HealthFirst51662-1647

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