Prescription drug · NDA
Oxytocin NDC 55154-9584
Oxytocin 10 [USP'U]/mL · Injection, Solution · Intramuscular, Intravenous · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-9584-5 | 55154958405 | 5 VIAL in 1 BAG (55154-9584-5) / 1 mL in 1 VIALMarketed from Nov 8, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLCNDC labeler code 55154
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018248
- Marketing start
- Listing expires
- Other FDA classes
- Increased Uterine Smooth Muscle Contraction or Tone (Physiologic effect)Oxytocin (Chemical structure)
- Identifiers
- Product ID 55154-9584_e511e878-05c0-416a-968f-d61fdbd59e68SPL ID e511e878-05c0-416a-968f-d61fdbd59e68SPL set ID 18fe8365-86e3-414e-84dc-c98e097a2f36RxCUI 1791721UNII 1JQS135EYNUPC 0055154958455
- 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.
- NDC on a medical claim
N455154958405followed by a unit qualifier and the quantityPackage 55154-9584-05. 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 .
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.
About NDC 55154-9584
- What is NDC 55154-9584?
- 55154-9584 is the product NDC for Oxytocin, Oxytocin 10 [USP'U]/mL injection, solution, listed with the FDA by Cardinal Health 107, 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?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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.
Related NDCs: other Oxytocin products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | Fresenius Kabi USA, LLC | 63323-012 | 63323-0012-07 |
| Oxytocin | Oxytocin 10 [USP'U]/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-012 | 63323-0012-1063323-0012-1163323-0012-30 |
Other NDCs under NDA 018248
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | Fresenius Kabi USA, LLC | 63323-012 |
| Oxytocin | Oxytocin 10 [USP'U]/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-012 |