Methylergonovine Maleate .2 mg Tablet, 7-count
Other active recalls for Methylergonovine Maleate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Ergot Derivative class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Methylergonovine belongs to a class of drugs called ergot alkaloids. Methylergonovine is used to prevent or treat bleeding from the uterus that can happen after childbirth or an abortion. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗- It's a medication given right after childbirth to help your uterus contract firmly and stop or prevent heavy bleeding. Sometimes the uterus doesn't tighten up on its own the way it...
- What exactly is methylergonovine used for?
- You'll typically take the tablet three or four times a day for up to one week after delivery, as your provider directs. One thing worth knowing: if you're taking it continuously in...
- How should I take the tablet form, and is there anything I should know about timing?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Methylergonovine Maleate — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 5C5403N26O
Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
-
UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
-
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
UNII W4888I119H
Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per each | Per 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. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Methylergonovine Maleate .2 mg 00093-3655-22 | Teva | 12 tablets | $4.351 | AB | Availability likely | — |
| Methylergonovine Maleate .2 mg 00904-7282-10 | Major | 20 tablets | $4.351 | AB | Availability likely | — |
| Methylergonovine Maleate .2 mg 60687-0813-94 | American | 20 tablets | $4.351 | AB | Availability likely | — |
| Methylergonovine Maleate .2 mg 69238-1605-02 | Amneal | 12 tablets | $4.351 | AB | Availability likely | — |
| Methylergonovine Maleate .2 mg 70010-0786-12 | Granules | 12 tablets | $4.351 | AB | Availability likely | — |
| Methylergonovine Maleate .2 mgthis 16571-0735-17 | Rising | 7 tablets | — | AB | FDA listed | — |
| Methergine .2 mg 27437-0050-01 | Lupin | 100 tablets | — | AB | FDA listed | — |
| Methylergonovine Maleate .2 mg 83400-0100-12 | Volley | 12 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 16571-0735-01 | 100 TABLET in 1 BOTTLE (16571-735-01) | — | — | 2021-01-15 | Active |
| 16571-0735-17 You're viewing this | 7 TABLET in 1 BOTTLE (16571-735-17) | — | — | 2021-01-15 | Active |
| 16571-0735-21 | 12 TABLET in 1 BOTTLE (16571-735-21) | $4.35 / ea | $52.21 | 2021-01-15 | Active |
| 16571-0735-28 | 28 TABLET in 1 BOTTLE (16571-735-28) | $4.35 / ea | $121.82 | 2021-01-15 | Active |
You're viewing the smallest of 4 pack sizes for this product.
This pack shows little to no recent Medicaid volume — the 12 tablets pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 16571-0735-17?
What is the difference between NDC 16571-0735-17 and NDC 16571-0735-21?
What NDC number is used to bill for this package of Methylergonovine Maleate .2 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Orally The recommended dosage of Methylergonovine Maleate is One tablet, 0.2 mg, orally 3 or 4 times daily in the puerperium for a maximum of 1 week.
⛔ Contraindications ▾
CONTRAINDICATIONS Hypertension; toxemia; pregnancy; and hypersensitivity.
⚠️ Warnings ▾
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 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 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 should be stored separately from medications intended for neonatal administration.
🤒 Adverse Reactions ▾
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 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 To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
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.
Beta-blockers Caution should be exercised when methylergonovine maleate 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.
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 is used concurrently with other vasoconstrictors, ergot alkaloids, or prostaglandins.
🤰 Pregnancy ▾
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 ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
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 ▾
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: 1. removal of offending drug by inducing emesis, gastric lavage, catharsis, and supportive diuresis. 2. maintenance of adequate pulmonary ventilation, especially if convulsions or coma develop.
3. correction of hypotension with pressor drugs as needed. 4. control of convulsions with standard anticonvulsant agents. 5. control of peripheral vasospasm with warmth to the extremities if needed.
🧬 Clinical Pharmacology ▾
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 I.V. administration is immediate; after I.M. administration, 2-5 minutes, and after oral administration, 5-10 minutes.
Pharmacokinetics Pharmacokinetic studies following an I.V. 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).
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED White to off-white, round shape, biconvex compressed tablets debossed with "C" on one side and "2" on the other side. Available in bottles of 7, 12, 28 and 100 tablets. Bottles of 7 NDC 16571-735-17 Bottles of 12 NDC 16571-735-21 Bottles of 28 NDC 16571-735-28 Bottles of 100 NDC 16571-735-01 STORE AND DISPENSE Tablets : Store at 20 - 25°C (68 - 77°F) excursions permitted to 15º to 30ºC (59º to 86ºF). [see USP Controlled Room Temperature]; Store in tight, light-resistant container Manufactured for: Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816 Made in India Code: TS/DRUGS/19/1993 Revised : 06/2025 PIR73501-01
📋 Description ▾
DESCRIPTION Methylergonovine maleate is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine maleate is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient : Methylergonovine maleate, USP, 0.2 mg.
Inactive ingredients : acacia, corn starch, gelatin, lactose monohydrate, methyl paraben, microcrystalline cellulose, povidone, propyl paraben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β( S )]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is: Methylergonovine -structure.jpg