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Cevimeline Hydrochloride 30 mg Capsule, 100-count — NDC 70771-1982-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cevimeline Hydrochloride 30 mg Capsule, 100-count — NDC 70771-1982-1 (Billing 70771-1982-01)

by Zydus Lifesciences Limited · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Cevimeline Hydrochloride 30 mg Capsule from Zydus Lifesciences Limited, marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 70771-1982-01
🏷️ FDA NDC (as labeled) 70771-1982-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 70771-1982-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70771 labeler · 1982 product · 1 package
Package marketed since
Apr 15, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7077119821 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1982-1
Product NDC 70771-1982
11-digit billing NDC 70771198201
RxCUI 309140
UNII P81Q6V85NP
Application # ANDA220267
SPL Set ID 1a29e9ab-edb0-4ae8-8f20-f43d122d2b43
Established class (EPC) Cholinergic Receptor Agonist
Mechanism of action Cholinergic Muscarinic Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-15
Route ORAL
Dosage form CAPSULE
Substance CEVIMELINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 309140
Why two NDCs? The FDA registers this code as 70771-1982-1 — a 5-4-1 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 package segment → 70771-1982-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cholinergic Receptor Agonist class.

Pharmacologic class Cholinergic Receptor Agonist
Drug family (ATC) Other parasympathomimetics
How it works Cholinergic Muscarinic Agonists
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

📗 Our plain-language guide HelloPharmacist
  • It treats dry mouth symptoms in people with Sjögren’s Syndrome. It comes as a capsule you take by mouth.
  • You take the capsule three times a day. Food slows how fast it is absorbed, so ask me about timing. Don’t take more than prescribed, since higher amounts haven’t been shown to help...
  • Sweating is the most common, and nausea, a runny nose and diarrhea can happen too. You may also notice extra saliva. Let your doctor know if they bother you.
  • Call if you have chest pain, heart rhythm changes, breathing trouble or vision changes. Be careful driving at night, since vision and depth perception can be affected.
📖 Read our full Cevimeline 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.24 $124.32 / 100 capsules
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
70771-1982-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2026-04-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cevimeline Hydrochloride 30 mg 00054-0334-25 Hikma 100 capsules $0.729 AB Availability likely —
cevimeline hydrochloride 30 mg 00713-0937-01 Cosette 100 capsules $0.729 AB Availability likely —
Cevimeline Hydrochloride 30 mg 16571-0657-10 Rising 100 capsules $0.729 AB Availability likely —
Cevimeline Hydrochloride 30 mg 33342-0216-11 Macleods 100 capsules $0.729 AB Availability likely —
Cevimeline Hydrochloride 30 mg 59651-0422-01 Aurobindo 100 capsules $0.729 — Availability likely —
Cevimeline 30 mg 63304-0479-01 Sun 100 capsules $0.729 AB Availability likely —
Cevimeline 30 mg 69452-0316-20 Bionpharma 100 capsules $0.729 AB Availability likely —
Cevimeline Hydrochloride 30 mg 72578-0208-01 Viona 100 capsules $0.729 AB Availability likely —
Evoxac 30 mg 00713-0883-01 Cosette 100 capsules $8.591 AB Availability likely —
cevimeline hydrochloride 30 mg 40032-0999-01 Novel 100 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 63629-9863-01 Bryant 30 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mgthis 70771-1982-01 Zydus 100 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 71335-2264-01 Bryant 30 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 71335-2326-01 Bryant 30 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 72162-2563-01 Bryant 100 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 72789-0457-01 PD-Rx 100 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 72888-0118-00 Advagen 1000 capsules — AB FDA listed —
Cevimeline Hydrochloride 30 mg 87063-0180-01 ASCLEMED 100 capsules — AB FDA listed —
cevimeline hydrochloride 30 mg 43386-0999-01 Lupin 100 capsules — AB FDA listed —
cevimeline hydrochloride 30 mg 71335-3168-01 Bryant 30 capsules — AB FDA listed —
cevimeline hydrochloride 30 mg 00054-0893-25 Hikma 100 capsules — AB FDA listed —
cevimeline hydrochloride 30 mg 87063-0324-01 ASCLEMED 100 capsules — 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Cevimeline inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII KZQ570MOA5
    A plant-based thickener and binder made from cellulose. It helps hold tablet ingredients together, controls how quickly the medicine dissolves, and improves texture in liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • 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 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 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

LabelerZydus Lifesciences Limited
Application holderZYDUS LIFESCIENCES GLOBAL FZE
FDA applicationANDA220267 (ANDA)
Labeler code70771
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio723 products on file

More NDCs from Zydus Lifesciences Limited labeler code 70771

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. Jump with a chip, search within the label, or expand everything.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 22 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Cevimeline Hydrochloride Capsules, 30 mg NDC 70771-1982-1 in bottles of 100 capsules with child resistant-closure Rx Only image

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

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Zydus Lifesciences Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70771-1980-01 · Zydus 70771-1988-06 · Zydus →
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.