HomeNDC LookupIngredientsMeprobamate › 69097-0975-07
Meprobamate 400 mg Tablet, 100-count — NDC 69097-0975-07 package photo

Meprobamate 400 mg Tablet, 100-count

by Cipla USA Inc. · 100 TABLET in 1 BOTTLE (69097-975-07)
NDC 69097-0975-07
🏷️ FDA NDC (as labeled) 69097-975-07 billing pads the product segment with a zero
Rx only Generic On market CIV
🗂️ 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 →

🆔 Identity & classification

FDA NDC (as labeled) 69097-975-07
Product NDC 69097-975
11-digit billing NDC 69097097507
NCPDP billing unit EA — each (per item)
RxCUI 197928, 197929
UNII 9I7LNY769Q
Application # ANDA040797
SPL Set ID 17d814e2-b277-4dce-8615-e7fd7cab773f
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-07
Route ORAL
Dosage form TABLET
Substance MEPROBAMATE
GPI-14 57200050000310
GCN Seq No 003714
GCN 13802
HICL code 001605
Ingredient (HICL) Meprobamate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2F
Therapeutic class — specific (HIC3) Anti-Anxiety Drugs
AHFS code 28:24.12.00
AHFS class Non-Benzodiazepine Anxiolytics
FDB label name MEPROBAMATE 400 MG TABLET
FDB brand name Meprobamate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 69097-975-07 — 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 → 69097-0975-07. 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 Carbamates class.

Drug family (ATC) Carbamates
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

LabelerCipla USA Inc.
Application holderINVAGEN PHARMACEUTICALS INC
FDA applicationANDA040797 (ANDA)
Labeler code69097
First marketedJun 2021
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio221 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

Label name MEPROBAMATE 400 MG TABLET Ingredient Meprobamate
📖 What it is MedlinePlus · NLM

Meprobamate is used to treat anxiety disorders or for short-term relief of the symptoms of anxiety in adults and children 6 years of age and older. Meprobamate is in a class of medications called tranquilizers. It works by slowing activity in the brain to allow for relaxation.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Meprobamate is prescribed to manage anxiety disorders or to give short-term relief from anxiety symptoms. It's not meant for the everyday stress most people feel — it's for anxiety...
  • Yes, and this is one of the most important things to know about this medication. Meprobamate can cause both physical and psychological dependence, especially if you take more than...
  • No — you should avoid alcohol while taking meprobamate. Alcohol and meprobamate both slow down your central nervous system, and together the effects add up in ways that can be unpr...
  • Is it safe to drink alcohol while taking meprobamate?
📖 Read our full Meprobamate 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.

💊 What it looks like

Color White
ShapeRound
ImprintI;4
Size11 mm
ScoringScored — splits in 2
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 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and 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.

5 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 DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $5.993 $599.31 / 100 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Apr 2022 Feb 2026 May 2026 Aug 2026 $6.040 $5.075
▲ Up 18% over the last 10 months.
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
Meprobamate 400 mgthis 69097-0975-07 Cipla 100 tablets $5.993 AA Availability likely
Meprobamate 400 mg 46708-0020-30 Alembic 30 tablets AA FDA listed
Meprobamate 400 mg 62332-0020-30 Alembic 30 tablets AA 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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 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.

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

Medicare Part D (outpatient prescription) spending for Meprobamate — 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 Meprobamate. 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
$217.4K
Claims incl. refills
566
Beneficiaries
309
Spend / beneficiary
$703.51
Spend / claim
$384.07
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69097-0975-07 You're viewing this 100 TABLET in 1 BOTTLE (69097-975-07) 2021-06-07 Active

📄 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.
🎯 Indications and Usage 75 words

INDICATIONS AND USAGE Meprobamate tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.Anxiety or tension associated with the stress of everyday life usually do not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is,more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

⏱️ Dosage and Administration 65 words

DOSAGE AND ADMINISTRATION Meprobamate Tablets USP: The usual adult daily dosage is 1200 mg to 1600 mg, in three or four divided doses; a daily dosage above 2400mg is not recommended. The usual daily dosage for children ages six to twelve years is 200 mg to 600 mg, in two or three divided doses. Not recommended for children under age 6 (see Usage in Children).

Contraindications 23 words

CONTRAINDICATIONS Acute intermittent porphyria as well as allergic or idiosyncratic reactions to meprobamate or related compounds such as carisoprodol, mebutamate, tybamate, or carbromal.

⚠️ Warnings ~2 min read

WARNINGS Drug Dependence Physical dependence, psychological dependence, and abuse have occurred. When chronic intoxication from prolonged use occurs, it usually involves ingestion of greater than recommended doses and is manifested by ataxia, slurred speech, and vertigo. Therefore, careful supervision of dose and amounts prescribed is advised, as well as avoidance of prolonged administration, especially for alcoholics and other patients with a known propensity for taking excessive quantities of drugs.

Sudden withdrawal of the drug after prolonged and excessive use may precipitate recurrence of pre-existing symptoms such as anxiety,anorexia, insomnia, or withdrawal reactions such as vomiting, ataxia,tremors, muscle twitching, confusional states, hallucinosis, and rarely, convulsive seizures. Such seizures are more likely to occur in persons with central nervous system damage or pre-existent or latent convulsive disorders. Onset of withdrawal symptoms occurs usually within 12 to 48 hours after discontinuation of meprobamate;symptoms usually cease within the next 12 to 48 hours.

When excessive dosage has continued for weeks or months, dosage should be reduced gradually over a period of one or two weeks rather than abruptly stopped. Alternatively, a long-acting barbiturate may be substituted, then gradually withdrawn. Potentially Hazardous Tasks Patients should be warned that meprobamate may impair the mental and/or physical abilities required for performance of potentially hazardous tasks such as driving or operating machinery.

Additive Effects Since the effects of meprobamate and alcohol or meprobamate and other CNS depressants or psychotropic drugs may be additive,appropriate caution should be exercised with patients who take more than one of these agents simultaneously. Usage in Pregnancy and Lactation An increased risk of congenital malformations associated with the use of minor tranquilizers (meprobamate, chlordiazepoxide and diazepam) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided.

The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug. Meprobamate passes the placental barrier.

It is present both in umbilical cord blood at or near maternal plasma levels and in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. When use of meprobamate is contemplated in breastfeeding patients, the drug's higher concentration in breast milk as compared to maternal plasma should be considered. Usage in Children Meprobamate tablets should not be administered to children under age six, since there is a lack of documented evidence for safety and effectiveness in this age group.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS Central Nervous System Drowsiness, ataxia, dizziness, slurred speech, headache, vertigo,weakness, paresthesias, impairment of visual accommodation,euphoria, overstimulation, paradoxical excitement, fast EEG activity. Gastrointestinal Nausea, vomiting, diarrhea. Cardiovascular Palpitation, tachycardia, various forms of arrhythmia, transient ECG changes, syncope; also hypotensive crisis (including one fatal case).

Allergic or Idiosyncratic Allergic or idiosyncratic reactions are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug. Milder reactions are characterized by an itchy, urticarial, or erythematous maculopapular rash which may be generalized or confined to the groin. Other reactions have included leukopenia, acute nonthrombocytopenic purpura, petechiae, ecchymoses, eosinophilia,peripheral edema, adenopathy, fever, fixed drug eruption with cross reaction to carisoprodol, and cross sensitivity between meprobamate/mebutamate and meprobamate/carbromal.

More severe hypersensitivity reactions, rarely reported, include hyperpyrexia, chills, angioneurotic edema, bronchospasm, oliguria and anuria. Also, anaphylaxis, erythema multiforme, exfoliative dermatitis, stomatitis, proctitis, Stevens-Johnson syndrome and bullous dermatitis, including one fatal case of the latter following administration of meprobamate in combination with prednisolone. In case of allergic or idiosyncratic reactions to meprobamate,discontinue the drug and initiate appropriate symptomatic therapy,which may include epinephrine, antihistamines, and in severe cases,corticosteroids.

In evaluating possible allergic reactions, also consider allergy to excipients. Hematologic (See also Allergic or Idiosyncratic ). Agranulocytosis and aplastic anemia have been reported.

These cases rarely were fatal. Rare cases of thrombocytopenic purpura have been reported. Other Exacerbation of porphyric symptoms.

🧓 Geriatric Use 82 words

Geriatric Use Clinical studies of meprobamate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses 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 ~2 min read

OVERDOSAGE Suicidal attempts with meprobamate have resulted in drowsiness,lethargy, stupor, ataxia, coma, shock, vasomotor, and respiratory collapse. Some suicidal attempts have been fatal. The following data on meprobamate tablets have been reported in the literature and from other sources.

These data are not expected to correlate with each case (considering factors such as individual susceptibility and length of time from ingestion to treatment), but represent the usual ranges reported. Acute simple overdose (meprobamate alone): Death has been reported with ingestion of as little as 12 g meprobamate and survival with as much as 40 g. Blood levels 0.5-2 mg% represents the usual blood level range of meprobamate after therapeutic doses.

The level may occasionally be as high as 3mg%. 3-10 mg% usually corresponds to findings of mild to moderate symptoms of overdosage, such as stupor or light coma. 10-20 mg% usually corresponds to deeper coma, requiring more intensive treatment.

Some fatalities occur. At levels greater than 20 mg%, more fatalities than survivals can be expected. Acute combined overdose (meprobamate with alcohol or other CNS depressants or psychotropic drugs): Since effects can be additive, a history of ingestion of a low dose of meprobamate plus any of these compounds (or of a relative low blood or tissue level) cannot be used as a prognostic indicator.

In cases where excessive doses have been taken, sleep ensues rapidly and blood pressure, pulse, and respiratory rates are reduced to basal levels. Any drug remaining in the stomach should be removed and symptomatic therapy given. Should respiration or blood pressure become compromised, respiratory assistance, central nervous system stimulants, and pressor agents should be administered cautiously as indicated.

Meprobamate is metabolized in the liver and excreted by the kidney. Diuresis, osmotic (mannitol) diuresis, peritoneal dialysis, and hemodialysis have been used successfully. Careful monitoring of urinary output is necessary and caution should be taken to avoid overhydration.

Relapse and death, after initial recovery, have been attributed to incomplete gastric emptying and delayed absorption. Meprobamate can be measured in biological fluids by two methods: colorimetric (Hoffman, A.J. and Ludwig, B.J.: J Amer Pharm Assn 48:740, 1959) and gas chromatographic (Douglas, J.F. et al: Anal Chern39: 956, 1967).

🧬 Clinical Pharmacology 31 words

CLINICAL PHARMACOLOGY Meprobamate is a carbamate derivative which has been shown in animal studies to have effects at multiple sites in the central nervous system including the thalamus and limbic system.

📦 How Supplied / Storage and Handling 112 words

HOW SUPPLIED Meprobamate Tablets USP 200 mg are white, round, biconvex tablets debossed with I and 7 on one side and bisect on the other. Supplied in bottles of 100. Bottles of 100: NDC 69097-974-07 Meprobamate Tablets USP 400 mg are white, round, biconvex tablets debossed with I and 4 on one side and bisect on the other.

Supplied in bottles of 100. Bottles of 100: NDC 69097-975-07 Dispense in well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Rev.

07/2026

📋 Description 76 words

DESCRIPTION Meprobamate is a white powder with a characteristic odor and a bitter taste. It is slightly soluble in water, freely soluble in acetone and alcohol, and sparingly soluble in ether. The structural formula of meprobamate is: C 9 H 18 N 2 O 4 M.W.218.25 Meprobamate Tablets USP 200 mg and 400 mg for oral administration contain the following inactive ingredients: microcrystalline cellulose,sodium starch glycolate, pre-gelatinized starch, colloidal silicondioxide, stearic acid and magnesium stearate.

STRUCTURE.jpg

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