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Carboprost Tromethamine 250 ug/mL Injection, Solution, 10 vials — NDC 83270-0002-02 package photo

Carboprost Tromethamine 250 ug/mL Injection, Solution, 10 vials

by ONESOURCE SPECIALTY PHARMA LIMITED · 10 VIAL in 1 CARTON (83270-002-02) / 1 mL in 1 VIAL (83270-002-01)
NDC 83270-0002-02
🏷️ FDA NDC (as labeled) 83270-002-02 billing pads the product segment with a zero
This package
Contains10 vials Pack sizes2 compare ↓
Also comes in: 10 vials 83270-0002-10
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 83270-002-02
Product NDC 83270-002
11-digit billing NDC 83270000202
RxCUI 238014
UNII U4526F86FJ
UPC 0383270002012
Application # ANDA216897
SPL Set ID 461f80d0-b66c-f093-e063-6294a90a8893
Established class (EPC) Prostaglandin Analog
Chemical class Prostaglandins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2025)
Marketing start 2023-11-01
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance CARBOPROST TROMETHAMINE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 83270-002-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 83270-0002-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Prostaglandin Analog class.

Pharmacologic class Prostaglandin Analog
Drug family (ATC) Prostaglandins
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerONESOURCE SPECIALTY PHARMA LIMITED
Application holderONESOURCE SPECIALTY PTE LTD
FDA applicationANDA216897 (ANDA)
Labeler code83270
First marketedNov 2023
Product typeHuman Prescription Drug
Portfolio53 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Carboprost tromethamine is used for two main situations, both handled in a hospital. First, it can be used to end a pregnancy between weeks 13 and 20 — including in complicated cas...
  • Carboprost is given as a deep injection into a muscle — usually in a hospital setting by trained medical staff. You will be under the care of the medical team throughout. The numbe...
  • How is carboprost given, and will I be awake for it?
  • The most common ones are stomach-related — vomiting, diarrhea, and nausea are very frequent and affect a large proportion of patients. Flushing, chills, and a temporary fever are a...
📖 Read our full Carboprost guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hemabate 250 ug/mL 00009-0856-05 Pharmacia 1 ml — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 00143-9442-10 Hikma 10 vials — AP FDA listed —
carboprost tromethamine 250 ug/mL 00409-0064-10 Hospira, 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 25021-0477-01 Sagent 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 42571-0435-72 Micro 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 43598-0698-58 Dr. 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 43598-0917-58 Dr. 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 43598-0919-58 Dr. 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 46708-0777-01 Alembic 1 vial — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 55150-0459-10 Eugia 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 62332-0777-10 Alembic 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 62559-0900-01 ANI 10 vials — — FDA listed —
Carboprost Tromethamine 250 ug/mL 65145-0132-10 Caplin 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 65219-0579-01 Fresenius 10 vials — AP FDA listed —
carboprost tromethamine 250 ug/mL 68083-0584-10 Gland 10 vials — AP FDA listed —
carboprost tromethamine 250 ug/mL 70121-1680-07 Amneal 10 vials — AP FDA listed —
carboprost tromethamine 250 ug/mL 70512-0859-05 SOLA 5 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 70594-0112-02 Xellia 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 71839-0137-10 BE 10 vials — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 81298-5010-03 Long 1 vial — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 81665-0202-01 Omnivium 1 ml — AP FDA listed —
Carboprost Tromethamine 250 ug/mLthis 83270-0002-02 ONESOURCE 10 vials — AP Discontinued —
Carboprost Tromethamine 250 ug/mL 43598-0179-10 Dr. 10 syringes — AP FDA listed —
carboprost tromethamine 250 ug/mL 70069-0825-10 Somerset 10 syringes — AP FDA listed —
Carboprost Tromethamine 250 ug/mL 72485-0525-10 Armas 10 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83270-0002-02 You're viewing this 10 VIAL in 1 CARTON (83270-002-02) / 1 mL in 1 VIAL (83270-002-01) 2023-11-01 Discontinued by firm
83270-0002-10 10 VIAL in 1 CARTON (83270-002-10) / 1 mL in 1 VIAL 2023-11-01 Active

Pack size FAQ

What quantity is in NDC 83270-0002-02?
NDC 83270-0002-02 contains 10 vials — 10 vial in 1 carton / 1 ml in 1 vial.
What is the difference between NDC 83270-0002-02 and NDC 83270-0002-10?
Both are Carboprost Tromethamine 250 ug/mL Injection, Solution — the drug itself is identical. NDC 83270-0002-02 is the 10 vials package, while NDC 83270-0002-10 is the 10 vials package.
What NDC number is used to bill for this package of Carboprost Tromethamine 250 ug/mL Injection, Solution?
Bill NDC 83270-0002-02 — the 11-digit billing format is 83270000202. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 83270-002-02, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 83270-0002-02, written without dashes as 83270000202. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 83270-0002-02, the first segment (83270) is the labeler code FDA assigned to ONESOURCE SPECIALTY PHARMA LIMITED; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (83270-0002-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ONESOURCE SPECIALTY PHARMA LIMITED is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning 46 words ▾

WARNINGS Carboprost tromethamine injection Sterile Solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Carboprost tromethamine injection should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

🎯 Indications and Usage ~1 min read ▾

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 for expulsion.

Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome.

In a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION 1. Abortion and Indications 1–4 An initial dose of 1 mL of Carboprost tromethamine injection Sterile Solution (containing the equivalent of 250 micrograms of carboprost) is to be administered deep in the muscle with a tuberculin syringe. Subsequent doses of 250 micrograms should be administered at 1½ to 3½ hour intervals depending on uterine response.

An optional test dose of 100 micrograms (0.4 mL) may be administered initially. The dose may be increased to 500 micrograms (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 micrograms (1 mL). The total dose administered of carboprost tromethamine should not exceed 12 milligrams and continuous administration of the drug for more than two days is not recommended.

2. For Refractory Postpartum Uterine Bleeding: An initial dose of 250 micrograms of carboprost tromethamine injection Sterile Solution (1 mL of Carboprost tromethamine injection) is to be given deep, intramuscularly. In clinical trials it was found that the majority of successful cases (73%) responded to single injections.

In some selected cases, however, multiple dosing at intervals of 15 to 90 minutes was carried out with successful outcome. The need for additional injections and the interval at which these should be given can be determined only by the attending physicians as dictated by the course of clinical events. The total dose of carboprost tromethamine injection USP should not exceed 2 milligrams (8 doses).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 198 words ▾

CONTRAINDICATIONS 1. Hypersensitivity (including anaphylaxis and angioedema) to Carboprost tromethamine injection Sterile Solution [ see ADVERSE REACTIONS, Post-marketing Experience] 2. Acute pelvic inflammatory disease 3.

Patients with active cardiac, pulmonary, renal or hepatic disease WARNINGS Carboprost tromethamine injection Sterile Solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Carboprost tromethamine injection should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

Carboprost tromethamine does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by Carboprost tromethamine could exhibit transient life signs. Carboprost tromethamine is not indicated if the fetus in utero has reached the stage of viability.

Carboprost tromethamine injection should not be considered a feticidal agent. Evidence from animal studies has suggested that certain other prostaglandins have some teratogenic potential. Although these studies do not indicate that Carboprost tromethamine injection is teratogenic, any pregnancy termination with Carboprost tromethamine injection that fails should be completed by some other means.

This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS The adverse effects of Carboprost tromethamine Sterile Solution are generally transient and reversible when therapy ends. The most frequent adverse reactions observed are related to its contractile effect on smooth muscle. In patients studied, approximately two-thirds experienced vomiting and diarrhea, approximately one-third had nausea, one-eighth had a temperature increase greater than 2° F, and one-fourteenth experienced flushing.

The pretreatment or concurrent administration of antiemetic and antidiarrheal drugs decreases considerably the very high incidence of gastrointestinal effects common with all prostaglandins used for abortion. Their use should be considered an integral part of the management of patients undergoing abortion with carboprost tromethamine injection. Of those patients experiencing a temperature elevation, approximately one-sixteenth had a clinical diagnosis of endometritis.

The remaining temperature elevations returned to normal within several hours after the last injection. Adverse effects observed during the use of carboprost tromethamine injection for abortion and for hemorrhage, not all of which are clearly drug related, in decreasing order of frequency include: Vomiting Nervousness Diarrhea Nosebleed Nausea Sleep disorders Flushing or hot flashes Dyspnea Chills or Shivering Tightness in chest Coughing Wheezing Headaches Posterior cervical Endometritis perforation Hiccough Weakness Dysmenorrhea-like Diaphoresis Pain Dizziness Paresthesia Blurred vision Backache Epigastric pain Muscular pain Excessive thirst Breast tenderness Twitching eyelids Eye pain Gagging, retching Drowsiness Dry throat Dystonia Sensation of choking Asthma Thyroid storm Injection site pain Syncope Tinnitus Palpitations Vertigo Rash Vaso-vagal syndrome Upper respiratory Dryness of mouth infection Hyperventilation Leg cramps Respiratory distress Perforated uterus Hematemesis Anxiety Taste alteration Chest pain Urinary tract infection Retained placental Septic shock fragment Torticollis Shortness of breath Lethargy Fullness of throat Hypertension Uterine sacculation Tachycardia Faintness, light- Pulmonary edema headedness Endometritis from Uterine rupture IUCD

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Carboprost tromethamine administered intramuscularly stimulates in the gravid uterus myometrial contractions similar to labor contractions at the end of a full term pregnancy. Whether or not these contractions result from a direct effect of carboprost on the myometrium has not been determined. Nonetheless, they evacuate the products of conception from the uterus in most cases.

Postpartum, the resultant myometrial contractions provide hemostasis at the site of placentation. Carboprost tromethamine also stimulates the smooth muscle of the human gastrointestinal tract. This activity may produce the vomiting or diarrhea or both that is common when carboprost tromethamine is used to terminate pregnancy and for use postpartum.

In laboratory animals and also in humans carboprost tromethamine can elevate body temperature. With the clinical doses of carboprost tromethamine used for the termination of pregnancy, and for use postpartum, some patients do experience transient temperature increases. In laboratory animals and in humans large doses of carboprost tromethamine can raise blood pressure, probably by contracting the vascular smooth muscle.

With the doses of carboprost tromethamine used for terminating pregnancy, this effect has not been clinically significant. In laboratory animals and also in humans carboprost tromethamine can elevate body temperature. With the clinical doses of carboprost tromethamine used for the termination of pregnancy, some patients do experience temperature increases.

In some patients, carboprost tromethamine may cause transient bronchoconstriction. Drug plasma concentrations were determined by radioimmunoassay in peripheral blood samples collected by different investigators from 10 patients undergoing abortion. The patients had been injected intramuscularly with 250 micrograms of carboprost at two hour intervals.

Blood levels of drug peaked at an average of 2060 picograms/mL one-half hour after the first injection then declined to an average concentration of 770 picograms/mL two hours after the first injection just before the second injection. The average plasma concentration one-half hour after the second injection was slightly higher (2663 picograms/mL) than that after the first injection and decreased again to an average of 1047 picograms/mL by two hours after the second injection. Plasma samples were collected from 5 of these 10 patients following additional injections of the prostaglandin.

The average peak concentrations of drug were slightly higher following each successive injection of the prostaglandin, but always decreased to levels less than the preceding peak values by two hours after each injection. Five women who had delivery spontaneously at term were treated immediately postpartum with a single injection of 250 micrograms of carboprost tromethamine. Peripheral blood samples were collected at several times during the four hours following treatment and carboprost tromethamine levels were determined by radioimmunoassay.

The highest concentration of carboprost tromethamine was observed at 15 minutes in two patients (3009 and 2916 picograms/mL), at 30 minutes in two patients (3097 and 2792 picograms/mL), and at 60 minutes in one patient (2718 picograms/mL).

📦 How Supplied / Storage and Handling 87 words ▾

HOW SUPPLIED Carboprost tromethamine injection, USP Sterile Solution is available in the following packages: 1 mL single-dose vial NDC 83270-002-01 10 x 1 mL single-dose vials NDC 83270-002-10 Each mL of carboprost tromethamine injection contains carboprost tromethamine equivalent to 250 mcg of carboprost. Carboprost tromethamine injection must be refrigerated at 2° to 8° C (36° to 46° F). Discard unused portion.

Rx only Manufactured by: OneSource Specialty Pharma Limited Revised: August 2025 To report SUSPECTED ADVERSE REACTIONS, contact OneSource at 1-888-217-8103 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

📋 Description 191 words ▾

DESCRIPTION Carboprost tromethamine injection, USP Sterile Solution, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in Carboprost tromethamine injection, USP. Four other chemical names are: 1.

(15S)-15-methyl prostaglandin F2α tromethamine salt 2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl- trans -1-octenyl]-1α-cyclopentyl]- cis -5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol 3. (15S)-9α,11α,15-trihydroxy-15-methylprosta- cis -5, trans -13-dienoic acid tromethamine salt 4.

(15S)-15-methyl PGF2α-THAM The structural formula is represented below: The molecular formula is C 25 H 47 O 8 N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder.

It generally melts between 95° and 105° C, depending on the rate of heating. Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL. Each mL of carboprost tromethamine injection, USP Sterile Solution contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative.

When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile. chemical-structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83270-0001-04 · ONESOURCE 83270-0003-01 · ONESOURCE →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.