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Acamprosate Calcium 333 mg Tablet, Delayed Release — NDC 00904-7213-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acamprosate Calcium 333 mg Tablet, Delayed Release — NDC 0904-7213-04 (Billing 00904-7213-04)

by Major Pharmaceuticals · 30 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

This is a package of Acamprosate Calcium 333 mg Tablet, Delayed Release from Major Pharmaceuticals, marketed since Jul 2013 and currently FDA-listed; retail pharmacies pay about $0.5891 per unit (NADAC). It is this product's only package size.

NDC 00904-7213-04
🏷️ FDA NDC (as labeled) 0904-7213-04 billing pads the labeler 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 →

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0904-7213-04
Product NDC 0904-7213
11-digit billing NDC 00904721304
NCPDP billing unit EA — each (per item)
RxCUI 835726
UNII 59375N1D0U
Application # ANDA202229
SPL Set ID ae6e79c0-a307-4888-b647-1b7be4cb9127
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-07-16
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance ACAMPROSATE CALCIUM
TE code (Orange Book) AB · RLD · RS

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

GPI-14 62802010200620
GPI class Acamprosate Calcium
GCN Seq No 025600
GCN 36441
HICL code 010731
Ingredient (HICL) Acamprosate Calcium
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C0
Therapeutic class — intermediate (HIC2) Affect Fluid/Acid-Base Balance/Metabolic Systems
HIC3 code C0D
Therapeutic class — specific (HIC3) Anti-Alcoholic Preparations
AHFS code 91:02.00.00
AHFS class Alcohol Deterrents (91:02)
FDB label name ACAMPROSATE CALC DR 333 MG TAB
FDB brand name Acamprosate Calcium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 025600
  • GCN: 36441
  • GPI-14 (Medi-Span): 62802010200620
  • HICL (First Databank): 010731
  • AHFS class code: 91:02.00.00
  • RxCUI (RxNorm): 835726
Why two NDCs? The FDA registers this code as 0904-7213-04 — a 4-4-2 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 labeler segment → 00904-7213-04. 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 Drugs used in alcohol dependence class.

Drug family (ATC) Drugs used in alcohol dependence
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 ACAMPROSATE CALC DR 333 MG TAB Ingredient Acamprosate Calcium
📖 What it is MedlinePlus · NLM

Acamprosate is used along with counseling and social support to help people who have stopped drinking large amounts of alcohol (alcoholism) to avoid drinking alcohol again. Acamprosate is in a class of medications called GABA agonist/glutamate antagonist. It works by balancing chemicals in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps people with alcohol dependence stay off alcohol after they have already stopped drinking. It works best alongside counseling and support, not on its own. It does not treat...
  • You swallow the tablets by mouth, usually three times a day. You can take them with or without food. If you eat three meals a day, taking them with meals is a handy routine. Follow...
  • The label says treatment should continue if you relapse. Talk with your prescriber and your support team so you can get back on track.
  • Diarrhea is the most common, and nausea, gas, dizziness, trouble sleeping and dry mouth can happen too. Many people can manage mild ones, but tell me or your doctor if they bother...
📖 Read our full Acamprosate guide →

Supplement & herbal interactions

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

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 $0.589 $17.67 / 30 tablet
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 · Q2 2026 $0.6813 $20.44 / 30 tablet
NADAC price history (per ea) — tap or hover for the price & month
Jun 2022 Dec 2023 Mar 2026 Sep 2026 $0.639 $0.492
▲ Up 11% over the last 19 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00904-7213-04 You're viewing this Main listing 30 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 2013-07-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acamprosate Calcium 333 mg 00378-6333-80 Mylan 180 tablets $0.589 AB Availability likely —
Acamprosate Calcium 333 mgthis 00904-7213-04 Major 1 tablet $0.589 AB Availability likely —
Acamprosate Calcium 333 mg 60687-0121-25 American 1 tablet $0.589 AB Availability likely —
Acamprosate Calcium 333 mg 69452-0353-25 Bionpharma 180 tablets $0.589 AB Availability likely —
Acamprosate Calcium 333 mg 70069-0860-18 Somerset 180 tablets $0.589 AB Availability likely —
Acamprosate Calcium 333 mg 00615-8560-39 NCS 30 tablets — AB FDA listed —
acamprosate calcium 333 mg 68382-0569-01 Zydus 100 tablets — AB FDA listed —
Acamprosate Calcium 333 mg 68462-0435-11 Glenmark 10 tablets — AB FDA listed —
acamprosate calcium 333 mg 70518-4616-00 REMEDYREPACK 1 tablet — AB FDA listed —
acamprosate calcium 333 mg 70771-1057-00 Zydus 1000 tablets — AB FDA listed —
Acamprosate Calcium 333 mg 00615-8660-39 NCS 30 tablets — AB 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

🏛️
2013
On the market since
Jul 2013
📍
2026
Currently FDA-listed
13 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.

What it looks like

Color White
ShapeRound
Imprint435
Size1 mm
ScoringNot scored
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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 9B9691B2N9
    Magnesium silicate is a mineral compound used in tablets and capsules as a glidant and anti-caking agent. It helps powder ingredients flow smoothly during manufacturing and prevents clumping in the final product.
  • 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 NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerMajor Pharmaceuticals
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA202229 (ANDA)
Labeler code00904
First marketedJul 2013
Product typeHuman Prescription Drug
Portfolio630 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.

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 152 words ▾

1 INDICATIONS AND USAGE Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment.

The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed. • Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation ( 1 , 14 ). • Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support ( 1 ).

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of acamprosate calcium delayed-release tablets is two 333 mg tablets (each dose should total 666 mg) taken three times daily. A lower dose may be effective in some patients. Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested in those patients who regularly eat three meals daily.

Treatment with acamprosate calcium delayed-release tablets should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses. Acamprosate calcium delayed-release tablets should be used as part of a comprehensive psychosocial treatment program. • Recommended dose: 666 mg (two 333 mg tablets) taken three times daily ( 2 ). • Dose reduction to one 333 mg tablet taken three times daily for patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min) ( 2.1 ). • Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) ( 2.1 , 4.2 , 5.1 , 8.6 , 12.3 ).

2.1Dosage in Renal Impairment For patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended. Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [see Contraindications ( 4.2 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 )] .

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Acamprosate calcium delayed-release tablets, 333 mg are white to off-white, round, biconvex, enteric-coated tablets debossed with “435” on one side and plain on the other side. Enteric-coated tablets, 333 mg ( 3 ).

⛔ Contraindications 109 words ▾

4 CONTRAINDICATIONS • Acamprosate calcium is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components ( 4.1 ). • Acamprosate calcium is contraindicated in patients with severe renal impairment ( 4.2 ).

4.1Hypersensitivity to Acamprosate Calcium Acamprosate calcium is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components.

4.2Severe Renal Impairment Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 )] .

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Dose reduction is required for patients with moderate renal impairment ( 5.1 ). • Monitor patients for depression or suicidal ideation and prompt patients, families, and caregivers to report such symptoms to the health care provider ( 5.2 ).

5.1Renal Impairment Treatment with acamprosate calcium in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min) requires a dose reduction [see Dosage and Administration ( 2.1 )] . Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [see Dosage and Administration ( 2.1 ), Contraindications ( 4.2 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 )] .

5.2Suicidality and Depression In controlled clinical trials of acamprosate calcium, adverse events of a suicidal nature (suicidal ideation, suicide attempts, completed suicides) were infrequent overall, but were more common in acamprosate calcium-treated patients than in patients treated with placebo (1.4% vs. 0.5% in studies of 6 months or less; 2.4% vs. 0.8% in year-long studies).

Completed suicides occurred in 3 of 2272 (0.13%) patients in the pooled acamprosate group from all controlled studies and 2 of 1962 patients (0.10%) in the placebo group. Adverse events coded as "depression" were reported at similar rates in acamprosate calcium-treated and placebo-treated patients. Although many of these events occurred in the context of alcohol relapse, and the interrelationship between alcohol dependence, depression and suicidality is well-recognized and complex, no consistent pattern of relationship between the clinical course of recovery from alcoholism and the emergence of suicidality was identified.

Alcohol-dependent patients, including those patients being treated with acamprosate calcium, should be monitored for the development of symptoms of depression or suicidal thinking. Families and caregivers of patients being treated with acamprosate calcium should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient's health care provider.

5.3Alcohol Withdrawal Use of acamprosate calcium does not eliminate or diminish withdrawal symptoms.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Common adverse events that occurred in any acamprosate calcium treatment group at a rate of 3% or greater and greater than the placebo group in controlled clinical trials with spontaneously reported adverse events are: accidental injury, asthenia, pain, anorexia, diarrhea, flatulence, nausea, anxiety, depression, dizziness, dry mouth, insomnia, paresthesia, pruritus and sweating ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinically significant serious adverse reactions associated with acamprosate calcium described elsewhere in labeling include suicidality and depression and acute kidney failure [s ee Warnings and Precautions (5.2) , and Adverse Reactions (6.2) ].

The adverse event data described below reflect the safety experience in over 7000 patients exposed to acamprosate calcium for up to one year, including over 2000 acamprosate calcium-exposed patients who participated in placebo-controlled trials. Adverse Events Leading to Discontinuation In placebo-controlled trials of 6 months or less, 8% of acamprosate calcium-treated patients discontinued treatment due to an adverse event, as compared to 6% of patients treated with placebo. In studies longer than 6 months, the discontinuation rate due to adverse events was 7% in both the placebo-treated and the acamprosate calcium-treated patients.

Only diarrhea was associated with the discontinuation of more than 1% of patients (2% of acamprosate calcium-treated vs. 0.7% of placebo-treated patients). Other events, including nausea, depression, and anxiety, while accounting for discontinuation in less than 1% of patients, were nevertheless more commonly cited in association with discontinuation in acamprosate calcium-treated patients than in placebo-treated patients.

Common Adverse Events Reported in Controlled Trials Common adverse events were collected spontaneously in some controlled studies and using a checklist in other studies. The overall profile of adverse events was similar using either method. Table 1 shows those events that occurred in any acamprosate calcium treatment group at a rate of 3% or greater and greater than the placebo group in controlled clinical trials with spontaneously reported adverse events.

The reported frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed, without regard to the causal relationship of the events to the drug. Table 1. Events Occurring at a Rate of at Least 3% and Greater than Placebo in any Acamprosate Calcium Treatment Group in Controlled Clinical Trials with Spontaneously Reported Adverse Events.

Body System/Preferred Term Number of Patients (%) with Events Acamprosate Calcium 1332 mg/day Acamprosate Calcium 1998 mg/day 1 Acamprosate Calcium Pooled 2 Placebo Number of patients in Treatment Group 397 1539 2019 1706 Number (%) of patients with an AE 248 (62%) 910 (59%) 1231 (61%) 955 (56%) Body as a Whole 121 (30%) 513 (33%) 685 (34%) 517 (30%) Accidental Injury*† 17 (4%) 44 (3%) 70 (3%) 52 (3%) Asthenia 29 (7%) 79 (5%) 114 (6%) 93 (5%) Pain 6 (2%) 56 ( 4%) 65 (3%) 55 (3%) Digestive System 85 (21%) 440 (29%) 574 (28%) 344 (20%) Anorexia 20 (5%) 35 (2%) 57 (3%) 44 (3%) Diarrhea 39 (10%) 257 (17%) 329 (16%) 166 (10%) Flatulence 4 (1%) 55 (4%) 63 (3%) 28 (2%) Nausea 11 (3%) 69 (4%) 87 (4%) 58 (3%) Nervous System 150 (38%) 417 (27%) 598 (30%) 500 (29%) Anxiety††** 32 (8%) 80 (5%) 118 (6%) 98 (6%) Depression 33 (8%) 63 (4%) 102 (5%) 87 (5%) Dizziness 15 (4%) 49 (3%) 67 (3%) 44 (3%) Dry mouth 13 (3%) 23 (1%) 3… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 41 words ▾

7 DRUG INTERACTIONS Acamprosate does not affect the pharmacokinetics of alcohol. The pharmacokinetics of acamprosate are not affected by alcohol, diazepam, or disulfiram, and clinically important interactions between naltrexone and acamprosate were not observed [see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Acamprosate calcium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus ( 8.1 ). • Nursing Mothers: Caution should be exercised when acamprosate calcium is administered to a nursing woman ( 8.3 ). • Renal Impairment: Dose reduction required for moderate renal impairment; contraindicated in severe renal impairment ( 2.1 , 4.2 , 5.1 , 8.6 , 12.3 )

8.1Pregnancy Teratogenic effects: Acamprosate calcium has been shown to be teratogenic in rats when given in doses that are approximately equal to the human dose (on a mg/m 2 basis) and in rabbits when given in doses that are approximately 3 times the human dose (on a mg/m 2 basis). Acamprosate calcium produced a dose-related increase in the number of fetuses with malformations in rats at oral doses of 300 mg/kg/day or greater (approximately equal to the maximum recommended human daily (MRHD) oral dose on a mg/m 2 basis).

The malformations included hydronephrosis, malformed iris, retinal dysplasia, and retroesophageal subclavian artery. No findings were observed at an oral dose of 50 mg/kg/day (approximately one-fifth the MRHD oral dose on a mg/m 2 basis). An increased incidence of hydronephrosis was also noted in Burgundy Tawny rabbits at oral doses of 400 mg/kg/day or greater (approximately 3 times the MRHD oral dose on a mg/m 2 basis).

No developmental effects were observed in New Zealand white rabbits at oral doses up to 1000 mg/kg/day (approximately 8 times the MRHD oral dose on a mg/m 2 basis). The findings in animals should be considered in relation to known adverse developmental effects of ethyl alcohol, which include the characteristics of fetal alcohol syndrome (craniofacial dysmorphism, intrauterine and postnatal growth retardation, retarded psychomotor and intellectual development) and milder forms of neurological and behavioral disorders in humans.

There are no adequate and well controlled studies in pregnant women. Acamprosate calcium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects: A study conducted in pregnant mice that were administered acamprosate calcium by the oral route starting on Day 15 of gestation through the end of lactation on postnatal day 28 demonstrated an increased incidence of still-born fetuses at doses of 960 mg/kg/day or greater (approximately 2 times the MRHD oral dose on a mg/m 2 basis).

No effects were observed at a dose of 320 mg/kg/day (approximately one-half the MRHD dose on a mg/m2 basis).

8.2Labor and Delivery The potential for acamprosate calcium to affect the duration of labor and delivery is unknown.

8.3Nursing Mothers In animal studies, acamprosate was excreted in the milk of lactating rats dosed orally with acamprosate calcium. The concentration of acamprosate in milk compared to blood was 1.3:1. It is not known whether acamprosate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when acamprosate calcium is administered to a nursing woman.

8.4Pediatric Use The safety and efficacy of acamprosate calcium have not been established in the pediatric population.

8.5Geriatric Use Forty-one of the 4234 patients in double-blind, placebo-controlled, clinical trials of acamprosate calcium were 65 years of age or older, while none were 75 years of age or over. There were too few patients in the ≥65 age group to evaluate any differences in safety or effectiveness for geriatric patients compared to younger patients. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Clinical Pharmacology ( 12.3 ), Adverse Reactions ( 6.1 ), and Dosage and Administr… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Teratogenic effects: Acamprosate calcium has been shown to be teratogenic in rats when given in doses that are approximately equal to the human dose (on a mg/m 2 basis) and in rabbits when given in doses that are approximately 3 times the human dose (on a mg/m 2 basis). Acamprosate calcium produced a dose-related increase in the number of fetuses with malformations in rats at oral doses of 300 mg/kg/day or greater (approximately equal to the maximum recommended human daily (MRHD) oral dose on a mg/m 2 basis).

The malformations included hydronephrosis, malformed iris, retinal dysplasia, and retroesophageal subclavian artery. No findings were observed at an oral dose of 50 mg/kg/day (approximately one-fifth the MRHD oral dose on a mg/m 2 basis). An increased incidence of hydronephrosis was also noted in Burgundy Tawny rabbits at oral doses of 400 mg/kg/day or greater (approximately 3 times the MRHD oral dose on a mg/m 2 basis).

No developmental effects were observed in New Zealand white rabbits at oral doses up to 1000 mg/kg/day (approximately 8 times the MRHD oral dose on a mg/m 2 basis). The findings in animals should be considered in relation to known adverse developmental effects of ethyl alcohol, which include the characteristics of fetal alcohol syndrome (craniofacial dysmorphism, intrauterine and postnatal growth retardation, retarded psychomotor and intellectual development) and milder forms of neurological and behavioral disorders in humans.

There are no adequate and well controlled studies in pregnant women. Acamprosate calcium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects: A study conducted in pregnant mice that were administered acamprosate calcium by the oral route starting on Day 15 of gestation through the end of lactation on postnatal day 28 demonstrated an increased incidence of still-born fetuses at doses of 960 mg/kg/day or greater (approximately 2 times the MRHD oral dose on a mg/m 2 basis).

No effects were observed at a dose of 320 mg/kg/day (approximately one-half the MRHD dose on a mg/m2 basis).

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use The safety and efficacy of acamprosate calcium have not been established in the pediatric population.

🧓 Geriatric Use 132 words ▾

8.5Geriatric Use Forty-one of the 4234 patients in double-blind, placebo-controlled, clinical trials of acamprosate calcium were 65 years of age or older, while none were 75 years of age or over. There were too few patients in the ≥65 age group to evaluate any differences in safety or effectiveness for geriatric patients compared to younger patients. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Clinical Pharmacology ( 12.3 ), Adverse Reactions ( 6.1 ), and Dosage and Administration ( 2.1 )] .

🆘 Overdosage 65 words ▾

10 OVERDOSAGE In all reported cases of acute overdosage with acamprosate calcium (total reported doses of up to 56 grams of acamprosate calcium), the only symptom that could be reasonably associated with acamprosate calcium was diarrhea. Hypercalcemia has not been reported in cases of acute overdose. A risk of hypercalcemia should be considered in chronic overdosage only. Treatment of overdose should be symptomatic and supportive.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of acamprosate in maintenance of alcohol abstinence is not completely understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition. In vitro and in vivo studies in animals have provided evidence to suggest acamprosate may interact with glutamate and GABA neurotransmitter systems centrally, and has led to the hypothesis that acamprosate restores this balance.

12.2Pharmacodynamics Pharmacodynamic studies have shown that acamprosate calcium reduces alcohol intake in alcohol-dependent animals in a dose-dependent manner and that this effect appears to be specific to alcohol and the mechanisms of alcohol dependence. Acamprosate calcium has negligible observable central nervous system (CNS) activity in animals outside of its effects on alcohol dependence, exhibiting no anticonvulsant, antidepressant, or anxiolytic activity. The administration of acamprosate calcium is not associated with the development of tolerance or dependence in animal studies.

Acamprosate calcium did not produce any evidence of withdrawal symptoms in patients in clinical trials at therapeutic doses. Post marketing data, collected retrospectively outside the U.S. have provided no evidence of acamprosate calcium abuse or dependence. Acamprosate calcium is not known to cause alcohol aversion and does not cause a disulfiram-like reaction as a result of ethanol ingestion.

12.3Pharmacokinetics Absorption The absolute bioavailability of acamprosate calcium after oral administration is about 11%. Steady-state plasma concentrations of acamprosate are reached within 5 days of dosing. Steady-state peak plasma concentrations after acamprosate calcium doses of 2 x 333 mg tablets three times daily average 350 ng/mL and occur at 3 to 8 hours post-dose.

Coadministration of acamprosate calcium with food decreases bioavailability as measured by C max and AUC, by approximately 42% and 23%, respectively. The food effect on absorption is not clinically significant and no adjustment of dose is necessary. Distribution The volume of distribution for acamprosate following intravenous administration is estimated to be 72 to 109 liters (approximately 1 L/kg) .

Plasma protein binding of acamprosate is negligible. Metabolism Acamprosate does not undergo metabolism. Elimination After oral dosing of 2 x 333 mg of acamprosate calcium, the terminal half-life ranges from approximately 20 to 33 hours.

Following oral administration of acamprosate calcium, the major route of excretion is via the kidneys as acamprosate. Special Populations Gender: Acamprosate calcium does not exhibit any significant pharmacokinetic differences between male and female subjects. Age: The pharmacokinetics of acamprosate calcium have not been evaluated in a geriatric population.

However, since renal function diminishes in elderly patients and acamprosate is excreted unchanged in urine, acamprosate plasma concentrations are likely to be higher in the elderly population compared to younger adults. Pediatrics: The pharmacokinetics of acamprosate calcium have not been evaluated in a pediatric population. Renal Impairment: Peak plasma concentrations after administration of a single dose of 2 x 333 mg acamprosate calcium tablets to patients with moderate or severe renal impairment were about 2-fold and 4-fold higher, respectively, compared to healthy subjects.

Similarly, elimination half-life was about 1.8-fold and 2.6-fold longer, respectively, compared to healthy subjects. There is a linear relationship between creatinine clearance values and total apparent plasma clearance, renal clearance and plasma half-life of acamprosate. A dose of 1 x 333 mg acamprosate calcium, three times daily, is recommended in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min, [see Use in Specific Populations ( 8.6 )] .

Acamprosate calcium is contraindicated in patients with seve… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 68 words ▾

12.1Mechanism of Action The mechanism of action of acamprosate in maintenance of alcohol abstinence is not completely understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition. In vitro and in vivo studies in animals have provided evidence to suggest acamprosate may interact with glutamate and GABA neurotransmitter systems centrally, and has led to the hypothesis that acamprosate restores this balance.

📦 How Supplied / Storage and Handling 98 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Acamprosate calcium delayed-release tablets, 333 mg are white to off-white, round, biconvex, enteric-coated tablets debossed with ‘435’ on one side and plain on the other side. Cartons of 30 delayed-release tablets (10 delayed-release tablets each blister pack x 3), NDC 0904-7213-04 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Storage and Handling Store at 20ºC to 25°C(68° F to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

📋 Description 185 words ▾

11 DESCRIPTION Acamprosate calcium delayed-release tablets are supplied as an enteric-coated tablet for oral administration. Acamprosate calcium, USP is a synthetic compound with a chemical structure similar to that of the endogenous amino acid homotaurine, which is a structural analogue of the amino acid neurotransmitter γ-aminobutyric acid and the amino acid neuromodulator taurine. Its chemical name is calcium bis [3-(acetylamino) propane-1-sulfonate].

Its chemical formula is C 10 H 20 CaN 2 O 8 S 2 and molecular weight is 400.5 g/mol. Its structural formula is: Acamprosate calcium, USP is a white to almost white powder, odorless or nearly odorless powder. It is freely soluble in water and practically insoluble in alcohol and methylene chloride.

Each acamprosate calcium delayed-release tablet contains acamprosate calcium, USP 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in acamprosate calcium delayed-release tablets include: colloidal silicon dioxide, crospovidone, methacrylic acid copolymer dispersion, magnesium silicate, magnesium stearate, microcrystalline cellulose, polyvinyl pyrollidone, propylene glycol, sodium starch glycolate, and talc. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product. structure.jpg

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION

17.1Information for Patients Physicians are advised to discuss the following issues with patients for whom they prescribe acamprosate calcium. Renal Impairment A lower dose is recommended for patients with moderate renal impairment. Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [ see Dosage and Administration ( 2.1 ), Contraindications ( 4.2 ), Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.6 ) ].

Suicidality and Depression Families and caregivers of patients being treated with acamprosate calcium should be alerted to the need to monitor patients for the emergence of symptoms of depression or suicidality, and to report such symptoms to the patient's health care provider [ see Warnings andPrecautions ( 5.2 ) ]. Alcohol Withdrawal Use of acamprosate calcium does not eliminate or diminish withdrawal symptoms [ see Warnings and Precautions ( 5.3 ) ]. Pregnancy and Breast Feeding • Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy. • Advise patients to notify their physician if they are breast-feeding.

Relapse to Drinking • Advise patients to continue acamprosate calcium therapy as directed, even in the event of relapse and remind them to discuss any renewed drinking with their physicians. • Advise patients that acamprosate calcium has been shown to help maintain abstinence only when used as a part of a treatment program that includes counseling and support. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number May 2025 logo

🍼 Nursing Mothers 63 words ▾

8.3Nursing Mothers In animal studies, acamprosate was excreted in the milk of lactating rats dosed orally with acamprosate calcium. The concentration of acamprosate in milk compared to blood was 1.3:1. It is not known whether acamprosate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when acamprosate calcium is administered to a nursing woman.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption The absolute bioavailability of acamprosate calcium after oral administration is about 11%. Steady-state plasma concentrations of acamprosate are reached within 5 days of dosing. Steady-state peak plasma concentrations after acamprosate calcium doses of 2 x 333 mg tablets three times daily average 350 ng/mL and occur at 3 to 8 hours post-dose.

Coadministration of acamprosate calcium with food decreases bioavailability as measured by C max and AUC, by approximately 42% and 23%, respectively. The food effect on absorption is not clinically significant and no adjustment of dose is necessary. Distribution The volume of distribution for acamprosate following intravenous administration is estimated to be 72 to 109 liters (approximately 1 L/kg) .

Plasma protein binding of acamprosate is negligible. Metabolism Acamprosate does not undergo metabolism. Elimination After oral dosing of 2 x 333 mg of acamprosate calcium, the terminal half-life ranges from approximately 20 to 33 hours.

Following oral administration of acamprosate calcium, the major route of excretion is via the kidneys as acamprosate. Special Populations Gender: Acamprosate calcium does not exhibit any significant pharmacokinetic differences between male and female subjects. Age: The pharmacokinetics of acamprosate calcium have not been evaluated in a geriatric population.

However, since renal function diminishes in elderly patients and acamprosate is excreted unchanged in urine, acamprosate plasma concentrations are likely to be higher in the elderly population compared to younger adults. Pediatrics: The pharmacokinetics of acamprosate calcium have not been evaluated in a pediatric population. Renal Impairment: Peak plasma concentrations after administration of a single dose of 2 x 333 mg acamprosate calcium tablets to patients with moderate or severe renal impairment were about 2-fold and 4-fold higher, respectively, compared to healthy subjects.

Similarly, elimination half-life was about 1.8-fold and 2.6-fold longer, respectively, compared to healthy subjects. There is a linear relationship between creatinine clearance values and total apparent plasma clearance, renal clearance and plasma half-life of acamprosate. A dose of 1 x 333 mg acamprosate calcium, three times daily, is recommended in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min, [see Use in Specific Populations ( 8.6 )] .

Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [see Dosage and Administration ( 2.1 ), Contraindications ( 4.2 ), Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.6 )] . Hepatic Impairment: Acamprosate is not metabolized by the liver and the pharmacokinetics of acamprosate calcium are not altered in patients with mild to moderate hepatic impairment (groups A and B of the Child-Pugh classification). No adjustment of dosage is recommended in such patients.

Alcohol-dependent subjects: A cross-study comparison of acamprosate calcium at doses of 2 x 333 mg three times daily indicated similar pharmacokinetics between alcohol-dependent subjects and healthy subjects. Drug-Drug Interactions Acamprosate had no inducing potential on the cytochrome CYP1A2 and 3A4 systems, and in vitro inhibition studies suggest that acamprosate does not inhibit in vivo metabolism mediated by cytochrome CYP1A2, 2C9, 2C19, 2D6, 2E1, or 3A4. The pharmacokinetics of acamprosate calcium were unaffected when co-administered with alcohol, disulfiram or diazepam.

Similarly, the pharmacokinetics of ethanol, diazepam and nordiazepam, imipramine and desipramine, naltrexone and 6-beta naltrexol were unaffected following co-administration with acamprosate calcium. However, co-administration of acamprosate calcium with naltrexone led to a 33% increase in the C max and a 25% increase in the AUC of acamprosate. No adjustment of dosage is recommended in such patients.

🧬 Pharmacodynamics 137 words ▾

12.2Pharmacodynamics Pharmacodynamic studies have shown that acamprosate calcium reduces alcohol intake in alcohol-dependent animals in a dose-dependent manner and that this effect appears to be specific to alcohol and the mechanisms of alcohol dependence. Acamprosate calcium has negligible observable central nervous system (CNS) activity in animals outside of its effects on alcohol dependence, exhibiting no anticonvulsant, antidepressant, or anxiolytic activity. The administration of acamprosate calcium is not associated with the development of tolerance or dependence in animal studies.

Acamprosate calcium did not produce any evidence of withdrawal symptoms in patients in clinical trials at therapeutic doses. Post marketing data, collected retrospectively outside the U.S. have provided no evidence of acamprosate calcium abuse or dependence. Acamprosate calcium is not known to cause alcohol aversion and does not cause a disulfiram-like reaction as a result of ethanol ingestion.

🔬 Clinical Studies 149 words ▾

14 CLINICAL STUDIES The efficacy of acamprosate calcium in the maintenance of abstinence was supported by three clinical studies involving a total of 998 patients who were administered at least one dose of acamprosate calcium or placebo as an adjunct to psychosocial therapy. Each study was a double-blind, placebo-controlled trial in alcohol-dependent patients who had undergone inpatient detoxification and were abstinent from alcohol on the day of randomization. Study durations ranged from 90 days to 360 days.

Acamprosate calcium proved superior to placebo in maintaining abstinence, as indicated by a greater percentage of subjects being assessed as continuously abstinent throughout treatment. In a fourth study, the efficacy of acamprosate calcium was evaluated in alcoholics, including patients with a history of polysubstance abuse and patients who had not undergone detoxification and were not required to be abstinent at baseline. This study failed to demonstrate superiority of acamprosate calcium over placebo.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Dietary administration of acamprosate calcium for 2 years to Sprague-Dawley rats at doses of 25, 100 and 400 mg/kg/day (up to 3 times the maximum recommended human daily (MRHD) oral dose on an AUC basis) and CD-1 mice at doses of 400, 1200 and 3600 mg/kg/day (up to 25 times the MRHD on an AUC basis) showed no evidence of increased tumor incidence. Acamprosate calcium was negative in all genetic toxicology studies conducted. Acamprosate calcium demonstrated no evidence of genotoxicity in an in vitro bacterial reverse point mutation assay (Ames assay) or an in vitro mammalian cell gene mutation test using Chinese Hamster Lung V79 cells.

No clastogenicity was observed in an in vitro chromosomal aberration assay in human lymphocytes and no chromosomal damage detected in an in vivo mouse micronucleus assay. Acamprosate calcium had no effect on fertility after treatment for 70 days prior to mating in male rats and for 14 days prior to mating, throughout mating, gestation and lactation in female rats at doses up to 1000 mg/kg/day (approximately 4 times the MRHD oral dose on a mg/m 2 basis). In mice, acamprosate calcium administered orally for 60 days prior to mating and throughout gestation in females at doses up to 2400 mg/kg/day (approximately 5 times the MRHD oral dose on a mg/m 2 basis) had no effect on fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Dietary administration of acamprosate calcium for 2 years to Sprague-Dawley rats at doses of 25, 100 and 400 mg/kg/day (up to 3 times the maximum recommended human daily (MRHD) oral dose on an AUC basis) and CD-1 mice at doses of 400, 1200 and 3600 mg/kg/day (up to 25 times the MRHD on an AUC basis) showed no evidence of increased tumor incidence. Acamprosate calcium was negative in all genetic toxicology studies conducted. Acamprosate calcium demonstrated no evidence of genotoxicity in an in vitro bacterial reverse point mutation assay (Ames assay) or an in vitro mammalian cell gene mutation test using Chinese Hamster Lung V79 cells.

No clastogenicity was observed in an in vitro chromosomal aberration assay in human lymphocytes and no chromosomal damage detected in an in vivo mouse micronucleus assay. Acamprosate calcium had no effect on fertility after treatment for 70 days prior to mating in male rats and for 14 days prior to mating, throughout mating, gestation and lactation in female rats at doses up to 1000 mg/kg/day (approximately 4 times the MRHD oral dose on a mg/m 2 basis). In mice, acamprosate calcium administered orally for 60 days prior to mating and throughout gestation in females at doses up to 2400 mg/kg/day (approximately 5 times the MRHD oral dose on a mg/m 2 basis) had no effect on fertility.

📄 Package Label / Principal Display Panel 24 words ▾

Package/Label Display Panel MAJOR® NDC 0904-7213-04 Unit Dose Acamprosate Calcium Delayed-Release Tablets 333 mg 30 TABLETS (3 x 10) Rx only 333mg carton label

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

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

Medicare Part D (outpatient prescription) spending for Acamprosate Calcium — the program that covers self-administered drugs. 5 manufacturers.
⚠️ 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 Acamprosate Calcium. 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
$1.56M
Claims incl. refills
13.6K
Beneficiaries
8K
Spend / beneficiary
$194.21
Spend / claim
$114.62
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.
← 00904-7212-61 · Major 00904-7216-61 · Major →
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.