What is NDC 63323-126?

63323-126 is the product NDC for Gemcitabine, Gemcitabine hydrochloride 2 g/50mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gemcitabine?

24 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gemcitabine NDC 63323-126 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-126Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0126Add 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
63323-126-03	6332301260363323012603	1 VIAL, SINGLE-DOSE in 1 BOX (63323-126-03) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 26, 2011

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): Gemcitabine
Generic name (nonproprietary): gemcitabine
Active ingredients: Gemcitabine hydrochloride — 2 g/50mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090799
Marketing start: Jul 26, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 63323-126_ce96743d-23fc-4de4-9df1-b650d64f4cbcSPL ID ce96743d-23fc-4de4-9df1-b650d64f4cbcSPL set ID c550dd16-a5e8-44be-87f2-210c15bbb513RxCUI 1719000, 1719003, 1719005UNII U347PV74ILUPC 0363323125530, 0363323126032, 0363323102135
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

N463323012603 followed by a unit qualifier and the quantity

Package 63323-0126-03. 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 Oct 14, 2024.

Indications (excerpt from the label)

Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine for Injection in combination with carboplatin is indicate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-126

What is NDC 63323-126?: 63323-126 is the product NDC for Gemcitabine, Gemcitabine hydrochloride 2 g/50mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gemcitabine.
What is the active ingredient?: Gemcitabine hydrochloride.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gemcitabine?: 24 other product NDCs are listed under this name. See all Gemcitabine 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 Gemcitabine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Gemcitabine	Gemcitabine hydrochloride 38 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9340	00143-9340-01
Gemcitabine	Gemcitabine hydrochloride 38 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9341	00143-9341-01
Gemcitabine	Gemcitabine hydrochloride 38 mg/mL	Injection, SolutionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9342	00143-9342-01
Gemcitabinegemcitabine hydrochloride	Gemcitabine hydrochloride 38 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-117	71288-0117-0671288-0117-2871288-0117-54
Gemcitabine	Gemcitabine hydrochloride 38 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-239	25021-0239-0525021-0239-2625021-0239-52
Gemcitabinegemcitabine hydrochloride	Gemcitabine hydrochloride 200 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	NorthStar Rx LLC	16714-909	16714-0909-01
Gemcitabinegemcitabine hydrochloride	Gemcitabine hydrochloride 1 g/1	Injection, Powder, Lyophilized, For solutionIntravenous	NorthStar Rx LLC	16714-930	16714-0930-01
Gemcitabinegemcitabine hydrochloride	Gemcitabine hydrochloride 200 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-113	71288-0113-10
Gemcitabinegemcitabine hydrochloride	Gemcitabine hydrochloride 1 g/1	Injection, Powder, Lyophilized, For solutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-114	71288-0114-50
Gemcitabinegemcitabine hydrochloride	Gemcitabine hydrochloride 200 mg/5.26mL	Injection, SolutionIntravenous	Mylan Institutional LLC	67457-616	67457-0616-10

All 25 Gemcitabine NDCs

Other NDCs under ANDA 090799

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

FDA NDC Directory listings under ANDA 090799
Product	Strength	Form · route	Labeler	Product NDC
Gemcitabine	Gemcitabine hydrochloride 200 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-102
Gemcitabine	Gemcitabine hydrochloride 1 g/25mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	63323-125