Prescription drug · NDA
Pitocin (Oxytocin) NDC 42023-130
Oxytocin 10 [iU]/mL · Injection · Intravenous · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42023-130-06 | 42023013006 | 6 VIAL in 1 CARTON (42023-130-06) / 50 mL in 1 VIALMarketed from May 1, 2018 |
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)
- Pitocin
- Generic name (nonproprietary)
- oxytocin
- Active ingredients
- Oxytocin — 10 [iU]/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Par Health USA, LLCNDC labeler code 42023
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018261
- Marketing start
- Listing expires
- Other FDA classes
- Increased Uterine Smooth Muscle Contraction or Tone (Physiologic effect)Oxytocin (Chemical structure)
- Identifiers
- Product ID 42023-130_b493de99-bebb-46c3-946c-09c0e9c43832SPL ID b493de99-bebb-46c3-946c-09c0e9c43832SPL set ID 6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1RxCUI 207315, 238013UNII 1JQS135EYN
- 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
N442023013006followed by a unit qualifier and the quantityPackage 42023-0130-06. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor. Antepartum: Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preecl…
Excerpt only. Read the full label for complete information.
About NDC 42023-130
- What is NDC 42023-130?
- 42023-130 is the product NDC for Pitocin (oxytocin), Oxytocin 10 [iU]/mL injection, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pitocin (Oxytocin).
- What is the active ingredient?
- Oxytocin.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 42023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pitocin?
- 1 other product NDC are listed under this name. See all Pitocin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pitocin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pitocinoxytocin | Oxytocin 10 [iU]/mL | InjectionIntravenous | Par Health USA, LLC | 42023-116 | 42023-0116-93 |
Other NDCs under NDA 018261
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 |
|---|---|---|---|---|
| Pitocinoxytocin | Oxytocin 10 [iU]/mL | InjectionIntravenous | Par Health USA, LLC | 42023-116 |