Isotretinoin 20 mg Capsule, 30-count
by Zydus Lifesciences Limited · 3 BLISTER PACK in 1 CARTON (70771-1558-8) / 10 CAPSULE in 1 BLISTER PACK
NDC 70771-1558-08
🏷️ FDA NDC (as labeled)
70771-1558-8
billing pads the package segment with a zero
This package
Contains30-count
Pack sizes2 compare ↓
Also priced by: Part D plans $4.13/unit — full pricing hub ↓
Also comes in:
100 capsules 70771-1558-04
Rx only
Generic
On market
Non-controlled
🗂️ 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 →
⚠️
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
FDA NDC (as labeled)
70771-1558-8
Product NDC
70771-1558
11-digit billing NDC
70771155808
UNII
EH28UP18IF
Application #
ANDA211568
SPL Set ID
dae33df0-386c-4db5-9759-7096e770ed17
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
2023-09-12
Route
ORAL
Dosage form
CAPSULE
Substance
ISOTRETINOIN
TE code (Orange Book)
AB1 · RLD · RS
Why two NDCs?
The FDA registers this code as 70771-1558-8 — 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 → 70771-1558-08. 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.
🏭 Manufacturer & labeler
LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA211568 (ANDA)
Labeler code70771
First marketedSep 2023
Product typeHuman Prescription Drug
Portfolio717 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
📖 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
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- 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Isotretinoin — tap one for details:
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.
ACETYL-L-CARNITINE
Insignificant Depletion
L-CARNITINE
Insignificant Depletion
PROPIONYL-L-CARNITINE
Insignificant Depletion
FOLIC ACID
Moderate Depletion
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.
💬 Questions about Isotretinoin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
Brown / Yellow
ShapeOval
Imprint1025
Size14 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 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
-
UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
-
UNII REK4960K2U
Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
-
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
-
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 PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII A2M91M918C
A plant-based oil derived from soybeans that has been chemically hardened to make it solid or semi-solid at room temperature. It acts as a binder, filler, and lubricant to help hold the tablet together and allow it to move smoothly during manufacturing and packaging.
-
UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
-
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII 58QVG85GW3
A synthetic polymer made from vinyl acetate and phthalic acid. It coats tablets and capsules to control when and where the medicine dissolves in the digestive system, protecting the contents from stomach acid.
-
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 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.
-
UNII 7G1J5DA97F
White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.
18 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.
💲 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 system | Per each | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Amnesteem 20 mg 00378-6612-93 | Mylan | 30 capsules | $1.861 | AB1 | Availability likely | — |
| Claravis 20 mg 00555-1055-56 | Teva | 10 capsules | $1.861 | AB1 | Availability likely | — |
| Isotretinoin 20 mg 00832-8302-30 | Upsher-Smith | 10 capsules | $1.861 | AB1 | Availability likely | — |
| Zenatane 20 mg 55111-0136-81 | Dr. | 10 capsules | $1.861 | AB1 | Availability likely | — |
| Zenatane 20 mg 68001-0653-17 | BluePoint | 10 capsules | $1.861 | AB1 | Availability likely | — |
| Isotretinoin 20 mg 68308-0782-30 | Mayne | 10 capsules | $1.861 | AB1 | Availability likely | — |
| Isotretinoin 20 mg 69238-1175-03 | Amneal | 10 capsules | $1.861 | AB1 | Availability likely | — |
| Isotretinoin 20 mg 00245-0571-01 | Upsher-Smith | 10 capsules | $4.942 | AB2 | Availability likely | — |
| Isotretinoin 20 mg 00591-2434-15 | Actavis | 30 capsules | $4.942 | AB2 | Availability likely | — |
| Isotretinoin 20 mg 57664-0021-97 | Sun | 30 capsules | $4.942 | AB2 | Availability likely | — |
| Isotretinoin 20 mg 59651-0632-03 | Aurobindo | 30 capsules | $4.942 | AB2 | Availability likely | — |
| Isotretinoin 20 mg 68308-0571-30 | Mayne | 10 capsules | $4.942 | AB2 | Availability likely | — |
| Isotretinoin 20 mg 70710-1575-08 | Zydus | 30 capsules | $4.942 | AB2 | Availability likely | — |
| Absorica 20 mg 10631-0116-31 | Sun | 30 capsules | $35.744 | AB2 | Availability likely | — |
| Isotretinoin 20 mg 69238-1255-03 | Amneal | 30 capsules | — | — | FDA listed | — |
| Isotretinoin 20 mg 70710-1023-04 | Zydus | 100 capsules | — | AB1 | FDA listed | — |
| Isotretinoin 20 mgthis 70771-1558-08 | Zydus | 30 capsules | — | AB1 | FDA listed | — |
| Isotretinoin 20 mg 70771-1663-08 | Zydus | 30 capsules | — | AB2 | FDA listed | — |
| Accutane 20 mg 72143-0252-30 | JG | 10 capsules | — | AB1 | FDA listed | — |
| Isotretinoin 20 mg 84386-0009-03 | Aurobindo | 30 capsules | — | — | 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
🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 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 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.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Isotretinoin — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 36%
Female · 63%
Unknown · 1%
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70771-1558-04 | 10 BLISTER PACK in 1 CARTON (70771-1558-4) / 10 CAPSULE in 1 BLISTER PACK | 2023-09-12 | Active |
| 70771-1558-08 You're viewing this | 3 BLISTER PACK in 1 CARTON (70771-1558-8) / 10 CAPSULE in 1 BLISTER PACK | 2023-09-12 | Active |
Pack size FAQ
What quantity is in NDC 70771-1558-08?
NDC 70771-1558-08 is a 30-count package — 3 blister pack in 1 carton / 10 capsule in 1 blister pack.
What is the difference between NDC 70771-1558-08 and NDC 70771-1558-04?
Both are Isotretinoin 20 mg Capsule — the drug itself is identical. NDC 70771-1558-08 is the 30-count package, while NDC 70771-1558-04 is the 100 capsules package.
What NDC number is used to bill for this package of Isotretinoin 20 mg Capsule?
Bill NDC 70771-1558-08 — the 11-digit billing format is 70771155808. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 FDA registers it as 70771-1558-8, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70771-1558-08, written without dashes as 70771155808. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70771-1558-08, the first segment (70771) is the labeler code FDA assigned to Zydus Lifesciences Limited; the middle segment (1558) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 capsules (70771-1558-04). Each has its own NDC and its own page — see the package list near the top of this page.
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.
📄 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.
📄 FDA label ▾
No readable label sections were found for this product.
No label section mentions that — try another word, or open the full label on DailyMed below.
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.