What is NDC 69539-112?

69539-112 is the product NDC for Azacitidine, Azacitidine 100 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by MSN LABORATORIES PRIVATE LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.

MSN LABORATORIES PRIVATE LIMITED, NDC labeler code 69539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Azacitidine?

22 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Azacitidine NDC 69539-112 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69539-112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69539-0112Add 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 NDC	11-digit (billing)	Package	Copy
69539-112-01	6953901120169539011201	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (69539-112-01)Marketed from May 18, 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): Azacitidine
Generic name (nonproprietary): azacitidine
Active ingredients: Azacitidine — 100 mg/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous, Subcutaneous
Labeler: MSN LABORATORIES PRIVATE LIMITEDNDC labeler code 69539
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212580
Marketing start: May 16, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 69539-112_149556cf-d002-4d8b-875b-062561da3f44SPL ID 149556cf-d002-4d8b-875b-062561da3f44SPL set ID d24f1fc5-17c6-4e0c-b852-72692e835cffRxCUI 485246UNII M801H13NRUUPC 0369539112012
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

N469539011201 followed by a unit qualifier and the quantity

Package 69539-0112-01. 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 Jul 4, 2024.

Indications (excerpt from the label)

Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). ( 1.1 ) 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69539-112

What is NDC 69539-112?: 69539-112 is the product NDC for Azacitidine, Azacitidine 100 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by MSN LABORATORIES PRIVATE LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Azacitidine.
What is the active ingredient?: Azacitidine.
Who is the labeler?: MSN LABORATORIES PRIVATE LIMITED, NDC labeler code 69539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Azacitidine?: 22 other product NDCs are listed under this name. See all Azacitidine 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 Azacitidine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Azacitidine	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Somerset Therapeutics LLC	70069-857	70069-0857-01
Azacitidine	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Reliance Life Sciences Private Limited	58458-002	58458-0002-02
Azacitidine	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Dr. Reddy's Laboratories Inc.	75907-225	75907-0225-11
Azacitidine	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	BluePoint Laboratories.	68001-620	68001-0620-54
Azacitidine	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Camber Pharmaceuticals, Inc.	31722-365	31722-0365-31
Azacitidine	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Sandoz Inc	0781-3491	00781-3491-94
Azacitidine	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Civica, Inc.	72572-020	72572-0020-01
Azacitidineazacitidine for	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Pilnova Pharma Inc	83774-102	83774-0102-01
Azacitidine	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Apotex Corp	60505-6271	60505-6271-01
Azacitidine	Azacitidine 100 mg/4mL	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Eugia US LLC	55150-393	55150-0393-01

All 23 Azacitidine NDCs

Other NDCs under ANDA 212580

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

FDA NDC Directory listings under ANDA 212580
Product	Strength	Form · route	Labeler	Product NDC
Azacitidine	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Sandoz Inc	0781-3491
Azacitidine	Azacitidine 100 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous, Subcutaneous	Civica, Inc.	72572-020