Prescription drug · ANDA
Carboprost Tromethamine NDC 81665-202
Carboprost tromethamine 250 ug/mL · Injection, Solution · Intramuscular · Omnivium Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81665-202-01 | 8166502020181665020201 | 1 mL in 1 AMPULE (81665-202-01)Marketed from May 15, 2025 | |
| 81665-202-10 | 8166502021081665020210 | 10 AMPULE in 1 CARTON (81665-202-10) / 1 mL in 1 AMPULE (81665-202-01)Marketed from May 15, 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
- Omnivium Pharmaceuticals LLCNDC labeler code 81665
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213118
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins (Chemical structure)
- Identifiers
- Product ID 81665-202_4cded8b1-0f1c-219d-e063-6294a90a64e2SPL ID 4cded8b1-0f1c-219d-e063-6294a90a64e2SPL set ID 84efd1c0-6323-4469-9535-237f96fcb383RxCUI 238014UNII U4526F86FJUPC 0381665202016
- 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
N481665020201followed by a unit qualifier and the quantityPackage 81665-0202-01. 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, USP 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 for expulsion. Carbopro…
Excerpt only. Read the full label for complete information.
About NDC 81665-202
- What is NDC 81665-202?
- 81665-202 is the product NDC for Carboprost Tromethamine, Carboprost tromethamine 250 ug/mL injection, solution, listed with the FDA by Omnivium Pharmaceuticals LLC. It has 2 package NDCs, 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?
- Omnivium Pharmaceuticals LLC, NDC labeler code 81665. 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 | Sagent Pharmaceuticals | 25021-477 | 25021-0477-01 |
| 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 |