NDC codes

FDA NDC Directory
Product NDC (as listed)71288-303Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71288-0303Add 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
71288-303-02712880303027128803030225 VIAL, MULTI-DOSE in 1 CARTON (71288-303-02) / 1 mL in 1 VIAL, MULTI-DOSE (71288-303-01)Marketed from Sep 24, 2020

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
Route
Intramuscular, Subcutaneous
Labeler
Meitheal Pharmaceuticals Inc.NDC labeler code 71288
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214390
Marketing start
Listing expires
Other FDA classes
Vitamin B 12 (Chemical structure)
Identifiers
Product ID 71288-303_65f0f72b-691f-4cbb-a5d7-7579a133f457SPL ID 65f0f72b-691f-4cbb-a5d7-7579a133f457SPL set ID ccf5b124-083d-4465-a666-c1bc6e84d630RxCUI 309594UNII P6YC3EG204
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

N471288030302 followed by a unit qualifier and the quantity

Package 71288-0303-02. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE: Cyanocobalamin is indicated for vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions ), use of a gluten-free diet i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71288-303

What is NDC 71288-303?
71288-303 is the product NDC for Cyanocobalamin, Cyanocobalamin 1000 ug/mL injection, listed with the FDA by Meitheal Pharmaceuticals Inc.. 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?
Meitheal Pharmaceuticals Inc., NDC labeler code 71288. 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 214390

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

FDA NDC Directory listings under ANDA 214390
ProductStrengthForm · routeLabelerProduct NDC
CyanocobalaminCyanocobalamin 1000 ug/mLInjectionIntramuscular, SubcutaneousGland Pharma Limited68083-449
cyanocobalaminCyanocobalamin 1000 ug/mLInjectionIntramuscular, SubcutaneousGland Pharma Limited68083-561
cyanocobalaminCyanocobalamin 1000 ug/mLInjectionIntramuscular, SubcutaneousGland Pharma Limited68083-562
CyanocobalaminCyanocobalamin 1000 ug/mLInjectionIntramuscular, SubcutaneousPlano Pharmaceuticals Inc.87188-111
cyanocobalaminCyanocobalamin 1000 ug/mLInjectionIntramuscular, SubcutaneousPlano Pharmaceuticals Inc.87188-112
cyanocobalaminCyanocobalamin 1000 ug/mLInjectionIntramuscular, SubcutaneousPlano Pharmaceuticals Inc.87188-113

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