What is NDC 68475-503?

68475-503 is the product NDC for Carmustine kit, listed with the FDA by Navinta LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Navinta LLC, NDC labeler code 68475. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Carmustine?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Carmustine NDC 68475-503 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-503Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0503Add 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
68475-503-01	6847505030168475050301	1 KIT in 1 CARTON (68475-503-01) * 3 mL in 1 VIAL (68475-502-01) * 30 mL in 1 VIAL, SINGLE-DOSE (68475-500-01)Marketed from Dec 29, 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): Carmustine
Generic name (nonproprietary): carmustine
Dosage form: Kit
Labeler: Navinta LLCNDC labeler code 68475
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210179
Marketing start: Dec 29, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 68475-503_14b0f256-a380-424d-a9d4-fafb6ec0e246SPL ID 14b0f256-a380-424d-a9d4-fafb6ec0e246SPL set ID 06a0322b-eb28-44e2-9925-88bebd8fa91bRxCUI 309012UPC 0368475500013, 0368475503014

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.

NDC on a medical claim

N468475050301 followed by a unit qualifier and the quantity

Package 68475-0503-01. 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 Nov 18, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Carmustine for injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. Multiple myeloma in combination with prednisone. Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs. Carmustine for injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Brain tumors glioblastoma,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68475-503

What is NDC 68475-503?: 68475-503 is the product NDC for Carmustine kit, listed with the FDA by Navinta LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Carmustine.
Who is the labeler?: Navinta LLC, NDC labeler code 68475. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Carmustine?: 12 other product NDCs are listed under this name. See all Carmustine 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 Carmustine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
carmustine	—	KitIntravenous	Dr. Reddy's Laboratories Inc.	75907-327	75907-0327-11
Carmustine	—	KitIntravenous	KVK-Tech, Inc.	10702-361	10702-0361-99
Carmustine	—	Kit	Alembic Pharmaceuticals Limited	46708-659	46708-0659-02
Carmustine	—	Kit	Alembic Pharmaceuticals Inc.	62332-659	62332-0659-02
Carmustine	—	Kit	Novadoz Pharmaceuticals LLC	72205-198	72205-0198-01
carmustine	—	KitIntravenous	Dr. Reddy's Laboratories Inc.	43598-628	43598-0628-57
Carmustine	—	KitIntravenous	Meitheal Pharmaceuticals Inc.	71288-126	71288-0126-90
Carmustine	—	Kit	Sandoz Inc.	0781-3474	00781-3474-32
Carmustine	—	Kit	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-790	23155-0790-41
carmustine	—	Kit	Zydus Pharmaceuticals USA Inc.	70710-1525	70710-1525-09

All 13 Carmustine NDCs

Other NDCs under ANDA 210179

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

FDA NDC Directory listings under ANDA 210179
Product	Strength	Form · route	Labeler	Product NDC
carmustine	—	Kit	Zydus Pharmaceuticals USA Inc.	70710-1525