Prescription drug · ANDA
Carboprost Tromethamine NDC 43598-919
Carboprost tromethamine 250 ug/mL · Injection, Solution · Intramuscular · Dr. Reddys Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-919-58 | 4359809195843598091958 | 10 VIAL, SINGLE-DOSE in 1 CARTON (43598-919-58) / 1 mL in 1 VIAL, SINGLE-DOSE (43598-919-11)Marketed from Feb 4, 2020 |
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
- Dr. Reddys Laboratories Inc.NDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211941
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins (Chemical structure)
- Identifiers
- Product ID 43598-919_b1121a1d-8942-a856-b89e-897fd580d20aSPL ID b1121a1d-8942-a856-b89e-897fd580d20aSPL set ID 2fd306a6-bf50-a354-46e5-d9fa8da619afRxCUI 238014UNII U4526F86FJUPC 0343598919119
- 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
N443598091958followed by a unit qualifier and the quantityPackage 43598-0919-58. 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 Carboprost tromethamine injection, 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: 1. Failure of expulsion of the fetus during the course of treatment by another method; 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4. 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 43598-919
- What is NDC 43598-919?
- 43598-919 is the product NDC for Carboprost Tromethamine, Carboprost tromethamine 250 ug/mL injection, solution, listed with the FDA by Dr. Reddys Laboratories Inc.. 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?
- Dr. Reddys Laboratories Inc., NDC labeler code 43598. 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 | 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 |
Other NDCs under ANDA 211941
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 | Dr. Reddy's Laboratories Inc. | 43598-179 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | Injection, SolutionIntramuscular | Dr. Reddy's Laboratories Inc. | 43598-698 |
| Carboprost Tromethamine | Carboprost tromethamine 250 ug/mL | Injection, SolutionIntramuscular | Dr. Reddys Laboratories Inc. | 43598-917 |