Prescription drug · ANDA
Carboprost Tromethamine NDC 25021-477
Carboprost tromethamine 250 ug/mL · Injection, Solution · Intramuscular · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-477-01 | 2502104770125021047701 | 10 VIAL in 1 CARTON (25021-477-01) / 1 mL in 1 VIALMarketed from Dec 1, 2025 |
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
- Labeler
- Sagent PharmaceuticalsNDC labeler code 25021
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217198
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins (Chemical structure)
- Identifiers
- Product ID 25021-477_8dcc3692-6db4-4b95-9ee9-c81db12c5d12SPL ID 8dcc3692-6db4-4b95-9ee9-c81db12c5d12SPL set ID ffc3a941-4d73-4273-a879-1565133a4d5dRxCUI 238014UNII U4526F86FJ
- 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
N425021047701followed by a unit qualifier and the quantityPackage 25021-0477-01. 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.
About NDC 25021-477
- What is NDC 25021-477?
- 25021-477 is the product NDC for Carboprost Tromethamine, Carboprost tromethamine 250 ug/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carboprost Tromethamine.
- What is the active ingredient?
- Carboprost tromethamine.
- Who is the labeler?
- Sagent Pharmaceuticals, NDC labeler code 25021. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Carboprost Tromethamine?
- 23 other product NDCs are listed under this name. See all Carboprost Tromethamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Carboprost Tromethamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | Injection, SolutionIntramuscular | Armas Pharmaceuticals Inc. | 72485-525 | 72485-0525-10 |
| carboprost tromethamine | Carboprost tromethamine 250 ug/mL | Injection, SolutionIntramuscular | Somerset Therapeutics, LLC | 70069-825 | 70069-0825-10 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | SolutionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0143-9442 | 00143-9442-10 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | Injection, SolutionIntramuscular | Omnivium Pharmaceuticals LLC | 81665-202 | 81665-0202-0181665-0202-10 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | Injection, SolutionIntramuscular | Caplin Steriles Limited | 65145-132 | 65145-0132-10 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | InjectionIntramuscular | ANI Pharmaceuticals, Inc. | 62559-900 | 62559-0900-01 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | Injection, SolutionIntramuscular | Micro Labs Limited | 42571-435 | 42571-0435-72 |
| carboprost tromethamine | Carboprost tromethamine 250 ug/mL | Injection, SolutionIntramuscular | Hospira, Inc. | 0409-0064 | 00409-0064-10 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | Injection, SolutionIntramuscular | Dr. Reddy's Laboratories Inc. | 43598-179 | 43598-0179-10 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | SolutionIntramuscular | Xellia Pharmaceuticals USA LLC | 70594-112 | 70594-0112-02 |
Other NDCs under ANDA 217198
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 | Injection, SolutionIntramuscular | Alembic Pharmaceuticals Limited | 46708-777 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | Injection, SolutionIntramuscular | Alembic Pharmaceuticals Inc. | 62332-777 |