Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of thes...
Ergomar® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or a so-called "histaminic cephalalgia".
For best results, dosage should start at the first sign of an attack. Early Administration Gives Maximum Effectiveness. At the first sign of an attack or to relieve symptoms after onset of an attack, one 2 mg tablet is placed under the tongue. Another tablet should be taken at half-hour intervals thereafter, if necessary, but dosage must not exceed three tablets in any 24hour period. Total weekly dosage should not...
Rx Only
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See also CONTRAINDICATIONS and WARNINGS section)
Ergotamine Tartrate Sublingual Tablets USP 2 mg
Inactive Ingredients: Microcrystalline Cellulose NF, Natural Peppermint Flavor Powder, Crospovidone NF, Saccharin Sodium USP Powder, D&C Yellow #10 Lake, Magnesium Stearate NF, FD&C Blue #1 Aluminum Lake.
Ergotamine is a alpha adrenergic blocking agent with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels and produces depression of central vasomotor centers. The compound also has the properties of serotonin antagonism. In comparison to hydrogenated ergotamine, the adrenergic blocking actions are less pronounced and vasoconstrictive actions are greater.
Pharmacokinetic interactions (increased blood levels of ergotamine) have been reported in patients treated orally with ergotamine and macrolide antibiotics (e.g., troleandomycin, clarithromycin, erythromycin), and in patients treated orally with ergotamine and protease inhibitors (e.g. ritonavir) presumably due to inhibition of cytochrome P450 3A metabolism of ergotamine (See CONTRAINDICATIONS). Ergotamine has also been shown to be an inhibitor of cytochrome P450 3A catalyzed reactions. No pharmacokinetic interactions involving other cytochrome P450 isoenzymes are known.
Ergomar® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or a so-called "histaminic cephalalgia".
Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities (See PRECAUTIONS: Drug Interactions), with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine was coadministered, at least one resulting in death. Because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole) (See WARNINGS: CYP 3A4 Inhibitors).
Ergomar® Sublingual Tablets may cause fetal harm when administered to pregnant women. Ergomar® Sublingual Tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus. Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function and sepsis.
Hypersensitivity to any of the components.
Coadministration of ergotamine with potent CYP 3A4 inhibitors such as protease inhibitors or macrolide antibiotics has been associated with serious adverse events; for this reason, these drugs should not be given concomitantly with ergotamine (See CONTRAINDIATIONS). While these reactions have not been reported with less potent CYP 3A4 inhibitors, there is a potential risk for serious toxicity including vasospasm when these drugs are used with ergotamine. Examples of less potent CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with ergotamine.
There have been a few reports of patients on ergotamine tartrate and caffeine therapy developing retroperitoneal and/or pleuropulmonary fibrosis. There have also been rare reports of fibrotic thickening of the aortic, mitral, tricuspid, and/or pulmonary valves with long-term continuous use of ergotamine tartrate and caffeine. Ergomar® Sublingual Tablets should not be used for chronic daily administration
(See DOSAGE AND ADMINISTRATION).
Although signs and symptoms of ergotism rarely develop even after long term intermittent use of the drug, care should be exercised to remain within the limits of recommended dosage. Ergotism is manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia. Ergotamine induces vasoconstriction by a direct action on vascular smooth muscle. In chronic intoxication with ergot derivatives, headache, intermittent claudication, muscle pains, numbness, coldness and pallor of the digits may occur. If the condition is allowed to progress untreated, gangrene can result. While most cases of ergotism associated with ergotamine treatment result from frank overdosage, some cases have involved apparent hypersensitivity. There are few reports of ergotism among patients taking doses within the recommended limits or for brief periods of time. In rare instances, patients, particularly those who have used the medication indiscriminately over long periods of time, may display withdrawal symptoms consisting of rebound headache upon discontinuation of the drug.
Patients should be advised that one Ergomar® Sublingual Tablet should be taken at the first sign of a migraine headache. No more than 2 tablets should be taken for any single migraine attack. No more than 5 tablets should be taken during any 7-day period. Administration of Ergomar® Sublingual Tablets should not exceed the dosing guidelines and should not be used for chronic daily administration (See DOSAGE AND ADMINISTRATION). Ergomar® Sublingual Tablets should be used only for migraine headaches. It is not effective for other types of headaches and it lacks analgesic properties. Patients should be advised to report to the physician immediately any of the following: numbness or tingling in the fingers and toes, muscle pain in the arms and legs, weakness in the legs, pain in the chest or temporary speeding or slowing of the heart rate, swelling or itching.
See CONTRAINDICATIONS and WARNINGS.
Ergomar® Sublingual Tablets (Ergotamine Tartrate Sublingual Tablets USP) should not be administered with other vasoconstrictors. Use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure. The beta-blocker Inderal (propranolol) has been reported to potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine. Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy.The blood levels of ergotamine-containing drugs are reported to be elevated by the concomitant administration of macrolide antibiotics and vasospastic reactions have been reported with therapeutic doses of the ergotamine-containing drugs when coadministered with these antibiotics.
There are no studies on the placental transfer or teratogenicity of Ergomar®. Ergotamine crosses the placenta in small amounts, although it does not appear to be embryotoxic in this quantity. However, prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone leading to reduced myometrial and placental blood flow may have contributed to fetal growth retardation observed in animals.
(See CONTRAINDICATIONS)
Ergomar® is contraindicated in pregnancy due to its oxytocic effects of ergotamine
(See CONTRAINDICATIONS)
Ergomar® is contraindicated in pregnancy due to its oxytocic effect which is maximal in the third trimester.
(See CONTRAINDICATIONS)
Ergot drugs are known to inhibit prolactin but there are no reports of decreased lactation with Ergomar®. Ergotamine is excreted in breast milk and may cause symptoms of vomiting diarrhea, weak pulse and unstable blood pressure in nursing infants. Because of the potential for serious adverse reactions in nursing infants from Ergomar®, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Cardiovascular: Vasoconstrictive complications of a serious nature may occur at times. These include ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial distress and pain, EKG changes and muscle pains. Although these effects occur most commonly with long-term therapy at relatively high doses, they have also been reported with short-term or normal doses. Other cardiovascular adverse effects include transient tachycardia or bradycardia and hypertension.
Gastrointestinal: Nausea and vomiting
Neurological: paresthesias, numbness, weakness, and vertigo.
Allergic: Localized edema and itching.
Fibrotic Complications: (See WARNINGS).
There have been reports of drug abuse and psychological dependence in patients on ergotamine tartrate therapy. Due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages with long-term use to avoid ergotism. (See PRECAUTIONS)
Symptoms include vomiting, numbness, tingling, pain and cyanosis of the extremities associated with diminished or absent peripheral pulses; hypertension or hypotension; drowsiness, stupor, coma, convulsions and shock. A case has been reported of reversible bilateral papillitis with ring scotomata in a patient who received five times the recommended daily adult dose over a period of 14 days. Treatment consists of removal of the offending drug. Maintenance of adequate pulmonary ventilation, correction of hypotension, and control of convulsions and blood pressure are important considerations. Treatment of peripheral vasospasm should consist of warmth, but not heat, and protection of the ischemic limbs. Vasodilators may be beneficial but caution must be exercised to avoid aggravating an already existent hypotension.
For best results, dosage should start at the first sign of an attack. Early Administration Gives Maximum Effectiveness. At the first sign of an attack or to relieve symptoms after onset of an attack, one 2 mg tablet is placed under the tongue. Another tablet should be taken at half-hour intervals thereafter, if necessary, but dosage must not exceed three tablets in any 24hour period. Total weekly dosage should not exceed five tablets (10 mg) in any one week. Ergomar® Sublingual Tablets should not be used for chronic daily administration.
Ergomar® Sublingual Tablets, 2 mg
(Ergotamine Tartrate Sublingual Tablets USP)
Ergomar® Sublingual Tablets are round, green tablets each containing 2 mg of ergotamine tartrate. They are debossed with the product identification code "LB2" on one side, and are supplied in individual foil strips packaged in a plastic child resistant canister containing 20 tablets (5 – 2 × 2 foil strips) NDC 10802-12020
Store at 20°- 25°C (68° - 77°F) [see USP Controlled Room Temperature]; excursions permitted to 15° - 30°C (59° - 86°F). Protect from light and heat. Keep out of reach of children.
Manufactured for:
Rosedale Therapeutics
Bristol, TN 37620 USA
By: Mikart, Inc.
Atlanta, GA 30318
©Rosedale Therapeutics
All Rights Reserved
Printed in the U.S.A.
Rev 04/2008
20 Tablets
(5 - 2×2 Foil Strips)
NDC 10802-1202-0
Rx Only
ERGOMAR®
Sublingual Tablets, 2 mg
(ergotamine tartrate tablets, USP)
Each tablets contains 2 mg ergotamine tartrate, USP.
DIRECTIONS: 1 tablet dissolved under tongue. Another
tablet should be taken at half-hour intervals thereafter, if
necessary, but dosage must not exceed 3 tablets in any
24 hour period. Total weekly dosage should not exceed 5
tablets (10mg) in any 1 week. Ergomar Sublingual Tablets
should not be used for chronic daily administration.
KEEP OUT OF REACH OF CHILDREN
Manufactured for:
RT
Rosedale
Therapeutics
Bristol, TN 37620 USA
By:
Mikart, Inc., Atlanta, GA 30318
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10802-1202-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b3f2-f424-e053-dadaa90a57ce | Ergomar® Sublingual Tablets, 2 mg (Ergotamine Tartrate Sublingual Tablets, USP) |
| 10802-1202-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b3f2-f424-e053-dadaa90a57ce | Ergomar® Sublingual Tablets, 2 mg (Ergotamine Tartrate Sublingual Tablets, USP) |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10802-1202-0 | EA - Each | 10802-1202 | f55ef9b6-3068-4c8c-aa5d-920fea54ceb4 | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Ergotamine Tartrate | ACTIVE INGREDIENT | MRU5XH3B48 | 1 | |
| Ergotamine | ACTIVE MOIETY | PR834Q503T | 1 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | 1 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| Peppermint | INACTIVE INGREDIENT | V95R5KMY2B | 1 | |
| Saccharin Sodium Dihydrate | INACTIVE INGREDIENT | SB8ZUX40TY | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10802-1202 | 10802-1202-0, 10802-1202-3 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Ergotamine Tartrate | MRU5XH3B48 | ACTIB |
| Cellulose, Microcrystalline | OP1R32D61U | IACT |
| Peppermint | V95R5KMY2B | IACT |
| Crospovidone | 68401960MK | IACT |
| Saccharin Sodium Dihydrate | SB8ZUX40TY | IACT |
| D&C Yellow No. 10 | 35SW5USQ3G | IACT |
| Magnesium Stearate | 70097M6I30 | IACT |
| FD&C Blue No. 1 | H3R47K3TBD | IACT |
| Aluminum Oxide | LMI26O6933 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / SUBLINGUAL | 0.23 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SOLUTION / ORAL | NA | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / ORAL | 43 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| Aluminum Oxide | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | GRANULE, FOR SOLUTION / ORAL | 5.5 mg/120ml | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | NA | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SYRUP / ORAL | 4 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GEL / DENTAL | NA | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / ORAL | 665 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / DENTAL | 0.05 %w/v | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / DENTAL | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | CAPSULE / ORAL | 24 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOLUTION / ORAL | 8 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GEL / TOPICAL | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SHAMPOO / TOPICAL | NA | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOAP / TOPICAL | 1.4 %w/w | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | ELIXIR / ORAL | 0.3 mg/15ml | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / BUCCAL | 0.4 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CONCENTRATE / ORAL | 0.03 mg/1ml | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| Saccharin Sodium Dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087693-001 | ERGOMAR | ERGOTAMINE TARTRATE | 2MG | TABLET / SUBLINGUAL | RLD, RS | 1983-02-24 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RLD, RS | 1983-02-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RLD, RS | 1983-02-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A087693-001 | ERGOMAR | 2MG | TABLET / SUBLINGUAL | RS | 1983-02-24 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 6ac058ea-d4f4-4fcd-83e1-5f2adb8652e6 | 1bfd4827-5123-4dbb-8f94-7b097f5bfd5c | 2012-09-08 | Boxed warning, Warnings, Adverse reactions | 6ac058ea-d4f4-4fcd-83e1-5f2adb8652e6 1bfd4827-5123-4dbb-8f94-7b097f5bfd5c |
Adverse event summaries are temporarily unavailable. Other product information remains available.