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METHYLERGONOVINE MALEATE .2 mg/mL Injection, Solution, 10 ampules — NDC 63704-004-01 (Billing 63704-0004-01)

by Pharmacist Pharmaceutical, LLC · 10 AMPULE in 1 BOX / 1 mL in 1 AMPULE

This is a package of 10 ampules of METHYLERGONOVINE MALEATE .2 mg/mL Injection, Solution from Pharmacist Pharmaceutical, LLC, marketed since Nov 2010 and currently FDA-listed. It is this product's only package size.

NDC 63704-0004-01
🏷️ FDA NDC (as labeled) 63704-004-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

⚠️
Other active recalls for Methylergonovine Maleate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 16, 2026 — Subpotent Drug (The Harvard Drug Group LLC) · FDA recall D-0609-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63704-004-01
Product NDC 63704-004
11-digit billing NDC 63704000401
NCPDP billing unit ML — per mL (volume)
RxCUI 996828
UNII IR84JPZ1RK
Application # ANDA040889
SPL Set ID 17ee0c79-ac98-4400-ae77-985978fca07e
Established class (EPC) Ergot Derivative
Chemical class Ergolines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-11-01
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance METHYLERGONOVINE MALEATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 29000020102005
GPI class Methylergonovine Maleate
GCN Seq No 003278
GCN 11340
HICL code 001446
Ingredient (HICL) Methylergonovine Maleate
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G3
Therapeutic class — intermediate (HIC2) Oxytocics
HIC3 code G3A
Therapeutic class — specific (HIC3) Oxytocics
AHFS code 76:00.00.00
AHFS class Oxytocics
FDB label name METHYLERGONOVINE 0.2 MG/ML AMP
FDB brand name Methylergonovine Maleate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003278
  • GCN: 11340
  • GPI-14 (Medi-Span): 29000020102005
  • HICL (First Databank): 001446
  • AHFS class code: 76:00.00.00
  • RxCUI (RxNorm): 996828
Why two NDCs? The FDA registers this code as 63704-004-01 — 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 → 63704-0004-01. 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 Ergot Derivative class.

Pharmacologic class Ergot Derivative
Drug family (ATC) Ergot alkaloids
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.

Clinical

Label name METHYLERGONOVINE 0.2 MG/ML AMP Ingredient Methylergonovine Maleate
📗 Our plain-language guide HelloPharmacist
  • It helps your uterus contract after delivery. That helps control heavy bleeding and helps the uterus shrink back to normal size. It can also be used to control uterine bleeding dur...
  • The injection is given by your care team. If you are prescribed tablets, you take them by mouth several times a day after delivery, for no more than a week. Follow your prescriber’...
  • Cramping or belly pain is common because the uterus is contracting. Nausea and vomiting can happen. Your blood pressure can go up or down, and headache can occur.
  • Get help right away for chest pain, trouble breathing, a sudden severe headache, a seizure, or signs of stroke. Also report numb, tingling or cold fingers and toes, a rash or swell...
📖 Read our full Methylergonovine guide →
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.

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 $7.77 $77.71 / 10 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63704-0004-01 You're viewing this Main listing 10 AMPULE in 1 BOX / 1 mL in 1 AMPULE 2010-11-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methylergonovine Maleate .2 mg/mL 00517-0740-20 American 20 vials — AP FDA listed —
Methylergonovine Maleate .2 mg/mL 51662-1556-01 HF 1 ml — AP FDA listed —
Methylergonovine Maleate .2 mg/mL 51662-1668-01 HF 1 ml — AP FDA listed —
Methylergonovine Maleate .2 mg/mL 51991-0144-17 Breckenridge 10 ampules — AP FDA listed —
Methylergonovine Maleate .2 mg/mL 63629-2074-01 Bryant 10 bottles — AP FDA listed —
Methylergonovine Maleate .2 mg/mLthis 63704-0004-01 Pharmacist 10 ampules — AP FDA listed —
Methylergonovine Maleate .2 mg/mL 72162-1592-02 Bryant 10 ampules — 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

🏛️
2010
On the market since
Nov 2010
📍
2026
Currently FDA-listed
16 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerPharmacist Pharmaceutical, LLC
Application holderBRECKENRIDGE PHARMACEUTICAL INC
FDA applicationANDA040889 (ANDA)
Labeler code63704
First marketedNov 2010
Product typeHuman Prescription Drug
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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔒 Drug Abuse and Dependence 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

INDICATIONS AND USAGE Following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.

⏱️ Dosage and Administration 67 words ▾

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Intramuscularly 1 mL, 0.2 mg, after delivery of the anterior shoulder, after delivery of the placenta, or during the puerperium. May be repeated as required, at intervals of 2-4 hours. Intravenously 1 mL, 0.2 mg, administered slowly over a period of no less than 60 seconds (See WARNINGS ).

⛔ Contraindications 6 words ▾

CONTRAINDICATIONS Hypertension; toxemia; pregnancy; and hypersensitivity.

⚠️ Warnings ~1 min read ▾

WARNINGS General This drug should not be administered I.V. routinely because of the possibility of inducing sudden hypertensive and cerebrovascular accidents. If I.V. administration is considered essential as a lifesaving measure, methylergonovine maleate should be given slowly over a period of no less than 60 seconds with careful monitoring of blood pressure. Intra-arterial or periarterial injection should be strictly avoided.

Caution should be exercised in the presence of impaired hepatic or renal function. Coronary artery disease Patients with coronary artery disease or risk factors for coronary artery disease (e.g., smoking, obesity, diabetes, high cholesterol) may be more susceptible to developing myocardial ischemia and infarction associated with methylergonovine-induced vasospasm. Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions The concomitant use of Methylergonovine Maleate and certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions or reduced therapeutic effect of Methylergonovine Maleate or the concomitant drug.

(see CONTRAINDICATION and DRUG INTERACTION ) Medication errors Inadvertent administration of Methylergonovine Maleate Injection to newborn infants has been reported. In these cases of inadvertent neonatal exposure, symptoms such as respiratory depression, convulsions, cyanosis and oliguria have been reported. Usual treatment is symptomatic.

However, in severe cases, respiratory and cardiovascular support is required. Methylergonovine Maleate Injection has been administered instead of vitamin K and Hepatitis B vaccine, medications which are routinely administered to the newborn. Due to the potential for accidental neonatal exposure, Methylergonovine Maleate Injection should be stored separately from medications intended for neonatal administration.

🤒 Adverse Reactions 163 words ▾

ADVERSE REACTIONS Clinical trials experience Common Adverse Reactions The most common adverse reaction is hypertension associated in several cases with seizure and/or headache. Hypotension has also been reported. Abdominal pain (caused by uterine contractions), nausea and vomiting have occurred occasionally.

Rare Adverse Reactions Rarely observed reactions have included: acute myocardial infarction, transient chest pains, vasoconstriction, vasospasm, coronary arterial spasm, bradycardia, tachycardia, dyspnea, hematuria, thrombophlebitis, water intoxication, hallucinations, leg cramps, dizziness, tinnitus, nasal congestion, diarrhea, diaphoresis, palpitation, rash, and foul taste. There have been rare isolated reports of anaphylaxis, without a proven causal relationship to the drug product. Post marketing Experience The following adverse drug reactions have been derived from post-marketing experience with Methylergonovine Maleate Injection via spontaneous case reports.

Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. Nervous system disorders Cerebrovascular accident, paraesthesia Cardiac disorders Ventricular fibrillation, ventricular tachycardia, angina pectoris, atrioventricular block

🔄 Drug Interactions ~1 min read ▾

Drug Interactions CYP 3A4 Inhibitors (e.g., Macrolide Antibiotics and Protease Inhibitors) There have been rare reports of serious adverse events in connection with the coadministration of certain ergot alkaloid drugs (e.g., dihydroergotamine and ergotamine) and potent CYP 3A4 inhibitors, resulting in vasospasm leading to cerebral ischemia and/or ischemia of the extremities. Although there have been no reports of such interactions with methylergonovine alone, strong and moderate CYP 3A4 inhibitors should not be co-administered with methylergonovine.

Examples of some of the strong CYP 3A4 inhibitors include saquinavir, grapefruit juice, nefazodone, macrolide antibiotics (e.g., troleandomycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g., ritonavir, indinavir, nelfinavir) or azole antifungals (e.g., ketoconazole, itraconazole, voriconazole). Moderate inhibitors include fluconazole, fluvoxamine and clotrimazole. Weak CYP 3A4 inhibitors should be administered with caution.

Weak inhibitors include chlorzoxazone, cilostazol, and ranitidine. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with methylergonovine. CYP3A4 inducers Drugs (e.g. nevirapine, rifampin) that are strong inducers of CYP3A4 are likely to decrease the pharmacological action of Methylergonovine Maleate Injection.

Beta-blockers Caution should be exercised when Methylergonovine Maleate Injection is used concurrently with beta-blockers. Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids. Anesthetics Anesthetics like halothane and methoxyflurane may reduce the oxytocic potency of Methylergonovine Maleate Injection.

Glyceryl trinitrate and other antianginal drugs Methylergonovine maleate produces vasoconstriction and can be expected to reduce the effect of glyceryl trinitrate and other antianginal drugs. No pharmacokinetic interactions involving other cytochrome P450 isoenzymes are known. Caution should be exercised when Methylergonovine Maleate Injection is used concurrently with other vasoconstrictors, ergot alkaloids, or prostaglandins.

🤰 Pregnancy 45 words ▾

Pregnancy Use of Methylergonovine Maleate is contraindicated during pregnancy because of its uterotonic effects. (See INDICATIONS AND USAGE ) Animal reproductive studies have not been conducted with Methylergonovine Maleate. It is not known whether Methylergonovine Maleate can cause fetal harm or can affect reproductive capacity.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 83 words ▾

Geriatric Use Clinical studies of methylergonovine maleate did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 218 words ▾

OVERDOSAGE Symptoms of acute overdose may include: nausea, vomiting, oliguria, abdominal pain, numbness, tingling of the extremities, rise in blood pressure, in severe cases followed by hypotension, respiratory depression, hypothermia, convulsions, and coma. Because reports of overdosage with methylergonovine maleate are infrequent, the lethal dose in humans has not been established. The oral LD 50 (in mg/kg) for the mouse is 187, the rat 93, and the rabbit 4.5.

Several cases of accidental Methylergonovine Maleate Injection in newborn infants have been reported, and in such cases 0.2 mg represents an overdose of great magnitude. However, recovery occurred in all but one case following a period of respiratory depression, hypothermia, hypertonicity with jerking movements, and convulsions. Also, several children 1-3 years of age have accidentally ingested up to 10 tablets (2 mg) with no apparent ill effects.

A postpartum patient took 4 tablets at one time in error and reported paresthesias and clamminess as her only symptoms. Treatment of acute overdosage is symptomatic and includes the usual procedures of: removal of offending drug by inducing emesis, gastric lavage, catharsis, and supportive diuresis. maintenance of adequate pulmonary ventilation, especially if convulsions or coma develop. correction of hypotension with pressor drugs as needed. control of convulsions with standard anticonvulsant agents. control of peripheral vasospasm with warmth to the extremities if needed.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action Methylergonovine maleate acts directly on the smooth muscle of the uterus and increases the tone, rate, and amplitude of rhythmic contractions. Thus, it induces a rapid and sustained tetanic uterotonic effect which shortens the third stage of labor and reduces blood loss. Pharmacodynamics The onset of action after IV administration is immediate; after I.M. administration, 2-5 minutes, and after oral administration, 5-10 minutes.

Pharmacokinetics Pharmacokinetic studies following an IV injection have shown that methylergonovine is rapidly distributed from plasma to peripheral tissues within 2-3 minutes or less. The bioavailability after oral administration was reported to be about 60% with no accumulation after repeated doses. During delivery, with intramuscular injection, bioavailability increased to 78%.

Ergot alkaloids are mostly eliminated by hepatic metabolism and excretion, and the decrease in bioavailability following oral administration is probably a result of first-pass metabolism in the liver. Bioavailability studies conducted in fasting healthy female volunteers have shown that oral absorption of a 0.2 mg methylergonovine tablet was fairly rapid with a mean peak plasma concentration of 3243 ± 1308 pg/mL observed at 1.12 ± 0.82 hours. A delayed gastrointestinal absorption (T max about 3 hours) of methylergonovine maleate tablet might be observed in postpartum women during continuous treatment with this oxytocic agent.

For a 0.2 mg intramuscular (IM) injection, a mean peak plasma concentration of 5918 ± 1952 pg/mL was observed at 0.41 ± 0.21 hours. The extent of absorption of the tablet, based upon methylergonovine plasma concentrations, was found to be equivalent to that of the IM solution given orally, and the extent of oral absorption of the IM solution was proportional to the dose following administration of 0.1, 0.2, and 0.4 mg. When given intramuscularly, the extent of absorption of methylergonovine maleate solution was about 25% greater than the tablet.

The volume of distribution (Vd ss /F) of intramuscularly administered methylergonovine was calculated to be 56.1 ± 17.0 liters, and the plasma clearance (CLp/F) was calculated to be 14.4 ± 4.5 liters per hour. The decline of plasma level of intramuscularly administered methylergonovine was biphasic with a mean elimination half-life of 3.39 hours (range 1.5 to 12.7 hours).

🧬 Mechanism of Action 45 words ▾

Mechanism of Action Methylergonovine maleate acts directly on the smooth muscle of the uterus and increases the tone, rate, and amplitude of rhythmic contractions. Thus, it induces a rapid and sustained tetanic uterotonic effect which shortens the third stage of labor and reduces blood loss.

📦 How Supplied / Storage and Handling 31 words ▾

HOW SUPPLIED Ampules 1 mL size Boxes of 10 NDC 63704-004-01 Store and Dispense Ampules Store in refrigerator, 2°C-8°C (36°F-46°F). Protect from light. Administer only if solution is clear and colorless.

📦 Storage and Handling 20 words ▾

Store and Dispense Ampules Store in refrigerator, 2°C-8°C (36°F-46°F). Protect from light. Administer only if solution is clear and colorless.

📋 Description 113 words ▾

DESCRIPTION Methylergonovine Maleate Injection, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Injection, USP is available in sterile ampules of 1 mL, containing 0.2 mg methylergonovine maleate for intramuscular or intravenous injection. Ampules: 1 mL, clear, colorless solution.

Active Ingredient: methylergonovine maleate, USP, 0.2 mg. Inactive Ingredients: maleic acid, 0.10 mg; sodium chloride, 7.0 mg; water for injection, qs to 1 mL. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9,10-didehydro- N -[l-(hydroxymethyl)propyl]-6-methyl-, [8β( S )]-, ( Z )-2-butenedioate (1:1) (salt).

Its structural formula is C 20 H 25 N 3 O 2 ∙C 4 H 4 O 4 Mol. wt. - 455.51 Chemical Structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Caution should be exercised in the presence of sepsis, obliterative vascular disease. Also use with caution during the second stage of labor. The necessity for manual removal of a retained placenta should occur only rarely with proper technique and adequate allowance of time for its spontaneous separation.

Drug Interactions CYP 3A4 Inhibitors (e.g., Macrolide Antibiotics and Protease Inhibitors) There have been rare reports of serious adverse events in connection with the coadministration of certain ergot alkaloid drugs (e.g., dihydroergotamine and ergotamine) and potent CYP 3A4 inhibitors, resulting in vasospasm leading to cerebral ischemia and/or ischemia of the extremities. Although there have been no reports of such interactions with methylergonovine alone, strong and moderate CYP 3A4 inhibitors should not be co-administered with methylergonovine.

Examples of some of the strong CYP 3A4 inhibitors include saquinavir, grapefruit juice, nefazodone, macrolide antibiotics (e.g., troleandomycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g., ritonavir, indinavir, nelfinavir) or azole antifungals (e.g., ketoconazole, itraconazole, voriconazole). Moderate inhibitors include fluconazole, fluvoxamine and clotrimazole. Weak CYP 3A4 inhibitors should be administered with caution.

Weak inhibitors include chlorzoxazone, cilostazol, and ranitidine. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with methylergonovine. CYP3A4 inducers Drugs (e.g. nevirapine, rifampin) that are strong inducers of CYP3A4 are likely to decrease the pharmacological action of Methylergonovine Maleate Injection.

Beta-blockers Caution should be exercised when Methylergonovine Maleate Injection is used concurrently with beta-blockers. Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids. Anesthetics Anesthetics like halothane and methoxyflurane may reduce the oxytocic potency of Methylergonovine Maleate Injection.

Glyceryl trinitrate and other antianginal drugs Methylergonovine maleate produces vasoconstriction and can be expected to reduce the effect of glyceryl trinitrate and other antianginal drugs. No pharmacokinetic interactions involving other cytochrome P450 isoenzymes are known. Caution should be exercised when Methylergonovine Maleate Injection is used concurrently with other vasoconstrictors, ergot alkaloids, or prostaglandins.

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies have been performed in animals to evaluate carcinogenic potential. The effect of the drug on mutagenesis or fertility has not been determined. Pregnancy Use of Methylergonovine Maleate is contraindicated during pregnancy because of its uterotonic effects.

(See INDICATIONS AND USAGE ) Animal reproductive studies have not been conducted with Methylergonovine Maleate. It is not known whether Methylergonovine Maleate can cause fetal harm or can affect reproductive capacity. Labor and Delivery The uterotonic effect of methylergonovine maleate is utilized after delivery to assist involution and decrease hemorrhage, shortening the third stage of labor.

Caution should be exercised during the second stage of labor. The necessity for manual removal of a retained placenta should occur only rarely with proper technique and adequate allowance of time for its spontaneous separation. Nursing Mothers Mothers should not breast-feed during treatment with Methylergonovine Maleate Injection and at least 12 hours after administration of the last dose.

Milk secreted during this period should be discarded. Methylergonovine Maleate may produce adverse effects in the breast-feeding infant. Methylergonovine Maleate may also reduce the yield of breast milk.

Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of methylergonovine… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 51 words ▾

Nursing Mothers Mothers should not breast-feed during treatment with Methylergonovine Maleate Injection and at least 12 hours after administration of the last dose. Milk secreted during this period should be discarded. Methylergonovine Maleate may produce adverse effects in the breast-feeding infant. Methylergonovine Maleate may also reduce the yield of breast milk.

🧬 Pharmacokinetics ~1 min read ▾

Pharmacokinetics Pharmacokinetic studies following an IV injection have shown that methylergonovine is rapidly distributed from plasma to peripheral tissues within 2-3 minutes or less. The bioavailability after oral administration was reported to be about 60% with no accumulation after repeated doses. During delivery, with intramuscular injection, bioavailability increased to 78%.

Ergot alkaloids are mostly eliminated by hepatic metabolism and excretion, and the decrease in bioavailability following oral administration is probably a result of first-pass metabolism in the liver. Bioavailability studies conducted in fasting healthy female volunteers have shown that oral absorption of a 0.2 mg methylergonovine tablet was fairly rapid with a mean peak plasma concentration of 3243 ± 1308 pg/mL observed at 1.12 ± 0.82 hours. A delayed gastrointestinal absorption (T max about 3 hours) of methylergonovine maleate tablet might be observed in postpartum women during continuous treatment with this oxytocic agent.

For a 0.2 mg intramuscular (IM) injection, a mean peak plasma concentration of 5918 ± 1952 pg/mL was observed at 0.41 ± 0.21 hours. The extent of absorption of the tablet, based upon methylergonovine plasma concentrations, was found to be equivalent to that of the IM solution given orally, and the extent of oral absorption of the IM solution was proportional to the dose following administration of 0.1, 0.2, and 0.4 mg. When given intramuscularly, the extent of absorption of methylergonovine maleate solution was about 25% greater than the tablet.

The volume of distribution (Vd ss /F) of intramuscularly administered methylergonovine was calculated to be 56.1 ± 17.0 liters, and the plasma clearance (CLp/F) was calculated to be 14.4 ± 4.5 liters per hour. The decline of plasma level of intramuscularly administered methylergonovine was biphasic with a mean elimination half-life of 3.39 hours (range 1.5 to 12.7 hours).

🧬 Pharmacodynamics 21 words ▾

Pharmacodynamics The onset of action after IV administration is immediate; after I.M. administration, 2-5 minutes, and after oral administration, 5-10 minutes.

🔒 Drug Abuse and Dependence 22 words ▾

DRUG ABUSE AND DEPENDENCE Methylergonovine maleate has not been associated with drug abuse or dependence of either a physical or psychological nature.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 30 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies have been performed in animals to evaluate carcinogenic potential. The effect of the drug on mutagenesis or fertility has not been determined.

📄 Package Label / Principal Display Panel 35 words ▾

PRINCIPAL DISPLAY PANEL - 1 mL Ampule Box NDC 63704-004-01 Methylergonovine Maleate Injection, USP 0.2 mg/mL Rx Only PHARMACIST PHARMACEUTICAL 10 x 1 mL ampules single dose PRINCIPAL DISPLAY PANEL - 1 mL Ampule Box

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
411
Units reimbursed last 4 qtrs
415
Gross reimbursed last 4 qtrs
$3.2K
Avg / prescription
$7.85
Avg / unit
$7.7712
Latest quarter Q1 2026
33Rx
Fee-for-service vs managed care ⓘ
95% MCO
Fee-for-service · 19 Rx Managed care · 392 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 395 units · 2.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 20 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.12.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 2.0 /100k
2 California 0.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Methylergonovine Maleate — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Methylergonovine Maleate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$50.8K
Claims incl. refills
25
Beneficiaries
15
Spend / beneficiary
$3,389.72
Spend / claim
$2,033.83
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) ✓ Available
“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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Pharmacist Pharmaceutical, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmacist Pharmaceutical, LLC 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.
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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.