NDC codes

FDA NDC Directory
Product NDC (as listed)68001-618Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0618Add 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
68001-618-3768001061837680010618371 VIAL in 1 CARTON (68001-618-37) / 20 mL in 1 VIALMarketed from May 3, 2024

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)
Decitabine
Generic name (nonproprietary)
decitabine
Active ingredients
Decitabine — 50 mg/20mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
BluePoint LaboratoriesNDC labeler code 68001
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212826
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 68001-618_3b490f98-eeec-b127-e063-6294a90aea54SPL ID 3b490f98-eeec-b127-e063-6294a90aea54SPL set ID 00caa305-fef4-471b-b9c3-4bcf5fe7b244RxCUI 636631UNII 776B62CQ27
Pharmacologic class
Nucleoside Metabolic Inhibitor

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

N468001061837 followed by a unit qualifier and the quantity

Package 68001-0618-37. 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)

Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de nov…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68001-618

What is NDC 68001-618?
68001-618 is the product NDC for Decitabine, Decitabine 50 mg/20mL injection, powder, lyophilized, for 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?
Decitabine.
What is the active ingredient?
Decitabine.
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 Decitabine?
20 other product NDCs are listed under this name. See all Decitabine 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 Decitabine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DecitabineDecitabine 50 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-71368001-0713-37
DecitabineDecitabine 50 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-64268001-0642-41
DecitabineDecitabine 50 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousCamber Pharmaceuticals, Inc.31722-30431722-0304-31
DecitabineDecitabine 50 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousSagent Pharmaceuticals25021-21925021-0219-20
decitabineDecitabine 50 mg/1Injection, Powder, Lyophilized, For solutionIntravenousHikma Pharmaceuticals USA Inc.0143-938500143-9385-01
DecitabineDecitabine 50 mg/26mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-37655150-0376-01
DecitabineDecitabine 50 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousMeitheal Pharmaceuticals Inc.71288-11971288-0119-20
DecitabineDecitabine 50 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousQilu Pharmaceutical Co., Ltd.67184-053567184-0535-01
DecitabineDecitabine 50 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousNivagen Pharmaceuticals, Inc.75834-19075834-0190-01
decitabineDecitabine 50 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousGland Pharma Limited68083-52868083-0528-01

All 21 Decitabine NDCs

Other NDCs under ANDA 212826

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

FDA NDC Directory listings under ANDA 212826
ProductStrengthForm · routeLabelerProduct NDC
DecitabineDecitabine 50 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousSagent Pharmaceuticals25021-219
DecitabineDecitabine 50 mg/20mLInjection, Powder, Lyophilized, For solutionIntravenousQilu Pharmaceutical Co., Ltd.67184-0535

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