Prescription drug · ANDA
Carboprost Tromethamine NDC 83270-002
Carboprost tromethamine 250 ug/mL · Injection, Solution · Intramuscular · ONESOURCE SPECIALTY PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83270-002-10 | 83270000210 | 10 VIAL in 1 CARTON (83270-002-10) / 1 mL in 1 VIALMarketed from Nov 1, 2023 |
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)
- Carboprost Tromethamine
- Generic name (nonproprietary)
- carboprost tromethamine
- Active ingredients
- Carboprost tromethamine — 250 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216897
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins (Chemical structure)
- Identifiers
- Product ID 83270-002_461f80d0-b66d-f093-e063-6294a90a8893SPL ID 461f80d0-b66d-f093-e063-6294a90a8893SPL set ID 461f80d0-b66c-f093-e063-6294a90a8893RxCUI 238014UNII U4526F86FJUPC 0383270002012
- Pharmacologic class
- Prostaglandin Analog
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
N483270000210followed by a unit qualifier and the quantityPackage 83270-0002-10. 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 Carboprost tromethamine injection Sterile Solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: Failure of expulsion of the fetus during the course of treatment by another method; Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity f…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216897
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 |
|---|---|---|---|---|
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | SolutionIntramuscular | Xellia Pharmaceuticals USA LLC | 70594-112 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | SolutionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0143-9442 |