NDC codes

FDA NDC Directory
Product NDC (as listed)83831-176Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83831-0176Add 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
83831-176-0483831017604838310176041 VIAL in 1 CARTON (83831-176-04) / 4 mL in 1 VIALMarketed from Sep 25, 2026

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)
Gobarden
Generic name (nonproprietary)
bendamustine hydrochloride
Active ingredients
Bendamustine hydrochloride — 100 mg/4mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
AVYXA Pharma, LLCNDC labeler code 83831
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 219014
Marketing start
Listing expires
Other FDA classes
Alkylating Activity (Mechanism)
Identifiers
Product ID 83831-176_d2d3080a-6cef-4a91-8035-6fd8b41109e6SPL ID d2d3080a-6cef-4a91-8035-6fd8b41109e6
Pharmacologic class
Alkylating Drug

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

N483831017604 followed by a unit qualifier and the quantity

Package 83831-0176-04. 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 83831-176

What is NDC 83831-176?
83831-176 is the product NDC for Gobarden (bendamustine hydrochloride), Bendamustine hydrochloride 100 mg/4mL injection, solution, listed with the FDA by AVYXA Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Gobarden (Bendamustine Hydrochloride).
What is the active ingredient?
Bendamustine hydrochloride.
Who is the labeler?
AVYXA Pharma, LLC, NDC labeler code 83831. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gobarden?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 219014

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

FDA NDC Directory listings under NDA 219014
ProductStrengthForm · routeLabelerProduct NDC
Bendamustine HydrochlorideBendamustine hydrochloride 100 mg/4mLInjectionIntravenousAvyxa Pharma, LLC83831-183

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