What is NDC 63323-012?

63323-012 is the product NDC for Oxytocin, Oxytocin 10 [USP'U]/mL injection, 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 Oxytocin?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxytocin NDC 63323-012 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0012Add 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
63323-012-07	63323001207	25 VIAL in 1 TRAY (63323-012-07) / 1 mL in 1 VIAL (63323-012-17)Marketed from Aug 10, 2000

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): Oxytocin
Generic name (nonproprietary): oxytocin
Active ingredients: Oxytocin — 10 [USP'U]/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 018248
Marketing start: Aug 10, 2000
Listing expires: Dec 31, 2026
Other FDA classes: Increased Uterine Smooth Muscle Contraction or Tone (Physiologic effect)Oxytocin (Chemical structure)
Identifiers: Product ID 63323-012_143745a3-4e90-49fc-9014-812276fe329fSPL ID 143745a3-4e90-49fc-9014-812276fe329fSPL set ID 6d7d1280-f286-4f39-89f3-2b96571810e6RxCUI 238013, 1791721UNII 1JQS135EYNUPC 0363323012175
Pharmacologic class: Oxytocic

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

N463323001207 followed by a unit qualifier and the quantity

Package 63323-0012-07. 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 15, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE IMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications. Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in order to achieve early vaginal delivery for fetal or maternal reasons. It is in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-012

What is NDC 63323-012?: 63323-012 is the product NDC for Oxytocin, Oxytocin 10 [USP'U]/mL injection, 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?: Oxytocin.
What is the active ingredient?: Oxytocin.
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 Oxytocin?: 6 other product NDCs are listed under this name. See all Oxytocin 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 Oxytocin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxytocin	Oxytocin 10 [USP'U]/mL	Injection, SolutionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-4233	70518-4233-00
Oxytocin	Oxytocin 10 [USP'U]/mL	Injection, SolutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	65219-021	65219-0021-01
Oxytocin	Oxytocin 10 [USP'U]/mL	InjectionIntramuscular, Intravenous	West-Ward Pharmaceuticals Corp	0143-9742	00143-9742-25
Oxytocin	Oxytocin 10 [USP'U]/mL	InjectionIntramuscular, Intravenous	West-Ward Pharmaceuticals Corp	0143-9743	00143-9743-25
Oxytocin	Oxytocin 10 [USP'U]/mL	Injection, SolutionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-9584	55154-9584-05

Other NDCs under NDA 018248

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

FDA NDC Directory listings under NDA 018248
Product	Strength	Form · route	Labeler	Product NDC
Oxytocin	Oxytocin 10 [USP'U]/mL	Injection, SolutionIntramuscular, Intravenous	Fresenius Kabi USA, LLC	65219-021
Oxytocin	Oxytocin 10 [USP'U]/mL	Injection, SolutionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-4233
Oxytocin	Oxytocin 10 [USP'U]/mL	Injection, SolutionIntramuscular, Intravenous	Cardinal Health 107, LLC	55154-9584