NDC codes

FDA NDC Directory
Product NDC (as listed)43598-919Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0919Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
43598-919-58435980919584359809195810 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.

How CPT relates to drug billing

NDC on a medical claim

N443598091958 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Carboprost Tromethamine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularArmas Pharmaceuticals Inc.72485-52572485-0525-10
carboprost tromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularSomerset Therapeutics, LLC70069-82570069-0825-10
Carboprost TromethamineCarboprost tromethamine 250 ug/mLSolutionIntramuscularHikma Pharmaceuticals USA Inc.0143-944200143-9442-10
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularSagent Pharmaceuticals25021-47725021-0477-01
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularOmnivium Pharmaceuticals LLC81665-20281665-0202-0181665-0202-10
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularCaplin Steriles Limited65145-13265145-0132-10
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjectionIntramuscularANI Pharmaceuticals, Inc.62559-90062559-0900-01
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularMicro Labs Limited42571-43542571-0435-72
carboprost tromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularHospira, Inc.0409-006400409-0064-10
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularDr. Reddy's Laboratories Inc.43598-17943598-0179-10

All 24 Carboprost Tromethamine NDCs

Other NDCs under ANDA 211941

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211941
ProductStrengthForm · routeLabelerProduct NDC
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularDr. Reddy's Laboratories Inc.43598-179
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularDr. Reddy's Laboratories Inc.43598-698
Carboprost TromethamineCarboprost tromethamine 250 ug/mLInjection, SolutionIntramuscularDr. Reddys Laboratories Inc.43598-917

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