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Isotretinoin 35 mg Capsule, 30-count — NDC 70771-1666-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Isotretinoin 35 mg Capsule, 30-count — NDC 70771-1666-8 (Billing 70771-1666-08)

by Zydus Lifesciences Limited · 3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK

This is a package of 30 capsules of Isotretinoin 35 mg Capsule from Zydus Lifesciences Limited, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 70771-1666-08
🏷️ FDA NDC (as labeled) 70771-1666-8 billing pads the package 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 →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Isotretinoin (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 6, 2026 — Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin (Teva Pharmaceuticals USA, Inc) · FDA recall D-0521-2026
Class II · Feb 24, 2026 — Failed Dissolution Specifications (MYLAN PHARMACEUTICALS INC) · FDA recall D-0399-2026
Class II · Jan 12, 2026 — Superpotent and Subpotent (Teva Pharmaceuticals USA, Inc) · FDA recall D-0446-2026
Class II · Jan 12, 2026 — Superpotent and Subpotent (Teva Pharmaceuticals USA, Inc) · FDA recall D-0445-2026
Class II · Mar 28, 2024 — Superpotent Drug: The 3-month stability result for assay was found to be above specification limit (Teva Pharmaceuticals USA, Inc) · FDA recall D-0439-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1666-8
Product NDC 70771-1666
11-digit billing NDC 70771166608
RxCUI 197843, 197844, 197845, 403930, 1547561, 1547565
UNII EH28UP18IF
Application # ANDA216633
SPL Set ID 245898e5-3a61-4d6a-8375-8b3a8b7364ac
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-09
Route ORAL
Dosage form CAPSULE
Substance ISOTRETINOIN
TE code (Orange Book) AB2 · RLD · RS
Quick answers
  • RxCUI (RxNorm): 197843
Why two NDCs? The FDA registers this code as 70771-1666-8 — 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 → 70771-1666-08. 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 Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Retinoids for topical use in acne, Retinoids for treatment of acne
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

📖 What it is MedlinePlus · NLM

Isotretinoin is used to treat severe recalcitrant nodular acne (a certain type of severe acne) that has not been helped by other treatments, such as antibiotics. Isotretinoin is in a class of medications called retinoids. It works by slowing the production of certain natural substances that can cause acne.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Isotretinoin causes extremely serious birth defects — even one dose during pregnancy can cause devastating harm to a developing baby. Because of that risk, the FDA requires everyon...
  • Why is there so much paperwork and testing before I can even get this prescription filled?
  • For most brands — including Accutane, Amnesteem, Claravis, and generic isotretinoin — yes, taking it with food is essential. Studies show that a fatty meal more than doubles the am...
  • Do I really need to take this with food every time?
📖 Read our full Isotretinoin guide →
4
Nutrient depletion considerations

Isotretinoin may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Isotretinoin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 $4.13 $123.90 / 30 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
70771-1666-08 You're viewing this Main listing 3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK 2025-06-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Isotretinoin 35 mg 00591-2501-15 Actavis 30 capsules — AB2 FDA listed —
Absorica 35 mg 10631-0134-31 Sun 30 capsules — AB2 FDA listed —
Isotretinoin 35 mg 57664-0024-97 Sun 30 capsules — AB2 FDA listed —
Isotretinoin 35 mg 59651-0635-03 Aurobindo 30 capsules — AB2 FDA listed —
Isotretinoin 35 mg 69238-1258-03 Amneal 30 capsules — — FDA listed —
Isotretinoin 35 mg 70710-1578-08 Zydus 30 capsules — AB2 FDA listed —
Isotretinoin 35 mgthis 70771-1666-08 Zydus 30 capsules — AB2 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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 Yellow / Orange / Green / Brown / Blue / Pink
ShapeCapsule
Imprint1579
Size24 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • 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 G6EP177239
    A waxy substance made from palm oil that has been chemically modified and combined with polyethylene glycol. It acts as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the medicine dissolves and is absorbed.
  • 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 8D4SNN7V92
    Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
  • 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 06XEA2VD56
    Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
  • UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

13 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 PHARMACEUTICALS USA INC
FDA applicationANDA216633 (ANDA)
Labeler code70771
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio720 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. Jump with a chip, search within the label, or expand everything.
💬 Medication Guide 📄 Package Label / Principal Display Panel
💬 Medication Guide 2 words ▾

SPL MEDGUIDE

📄 Package Label / Principal Display Panel 94 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1662-8 Isotretinoin Capsules USP, 10 mg 30 Capsules Rx only NDC 70771-1663-8 Isotretinoin Capsules USP, 20 mg 30 Capsules Rx only NDC 70771-1664-8 Isotretinoin Capsules USP, 25 mg 30 Capsules Rx only NDC 70771-1665-8 Isotretinoin Capsules USP, 30 mg 30 Capsules Rx only NDC 70771-1666-8 Isotretinoin Capsules USP, 35 mg 30 Capsules Rx only NDC 70771-1667-8 Isotretinoin Capsules USP, 40 mg 30 Capsules Rx only 10 mg 10 mg 20 mg 20 mg 25 mg 25 mg 30 mg 30 mg 35 mg 35 mg 40 mg 40 mg

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 Isotretinoin — the program that covers self-administered drugs. 7 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 Isotretinoin. 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
$626.8K
Claims incl. refills
2.6K
Beneficiaries
1.7K
Spend / beneficiary
$365.92
Spend / claim
$238.25
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.

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.
← 70771-1665-08 · Zydus 70771-1667-08 · 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.