HomeNDC LookupRxCUI directory › RxCUI 197845

Isotretinoin 40 MG Oral Capsule — RxCUI 197845

RxNorm drug concept · Semantic clinical drug
RxCUI 197845 Semantic clinical drug · SCD ● Current RxNorm concept 84 FDA products 91 package NDCs Snapshot Jul 14, 2026

What you’re looking at: the standardized identity of one medicine, as the U.S. drug-data system sees it. Below — every FDA-listed product, package code, price benchmark, and billing code that maps to it.

🗂️ Key Facts

RxCUI197845
Official nameIsotretinoin 40 MG Oral Capsule
Concept typeSemantic clinical drug (SCD)
RxNorm statusCurrent RxNorm concept
FDA products mapped84
Package NDCs mapped91
Reported Medicaid activity (SDUD)212,383 prescriptions · 51 state & territory Medicaid programs · latest period Q4 2025
RxNorm release07/06/2026
Snapshot dataJul 14, 2026

📖 Skip the Codes — Read It in Plain English.

Our pharmacist-built guide to Isotretinoin: what it is, how it’s used, side effects, and interactions.

📗 Our plain-language guide HelloPharmacist
  • Isotretinoin is one of the most tightly controlled medications in the U.S. because it causes extremely severe birth defects — even a single short exposure during pregnancy can be d...
  • Why do I have to go through so many steps just to get this prescription?
  • For most isotretinoin products — including Accutane, Amnesteem, Claravis, and generic isotretinoin capsules — yes, food is essential. Eating with your dose more than doubles how mu...
  • Do I really need to take this with food every time?
📖 Read our full Isotretinoin guide →

🕸️ Concept Web — How Isotretinoin 40 MG Oral Capsule Connects

One RxCUI never lives alone. Follow the path from the raw ingredient down to the exact strength-and-form concepts FDA products carry — every stop is a real RxNorm concept with its own identifier. Hover or focus any chip for what it means.
This page's concept Isotretinoin 40 MG Oral Capsule RxCUI 197845

Every web starts here: one RxCUI, one fixed meaning in the RxNorm vocabulary.

  1. Ingredients 1

    The active substance itself — no strength, form, or brand attached yet.

    • Isotretinoin 6064
  2. Brand names 6

    The same medicine's trade names. A brand name alone says nothing about strength or form.

    • Absorica 1299198
    • Accutane 202795
    • Amnesteem 404854
    • Claravis 405944
    • Myorisan 1242606
    • Zenatane 1373328
  3. Dose forms 24

    The ingredient poured into a form — tablet, solution, cream — still without one fixed strength.

    • Isotretinoin Oral Capsule 370721
    • Isotretinoin Oral Product 1159761
    • Isotretinoin Pill 1159762
    • Isotretinoin Oral Capsule [Absorica] 1299200
    • Isotretinoin Oral Capsule [Accutane] 366231
    • Isotretinoin Oral Capsule [Amnesteem] 405789
    • Isotretinoin Oral Capsule [Claravis] 835772
    • Isotretinoin Oral Capsule [Myorisan] 1242608
    • +16 more in this family
  4. Clinical & branded drugs 13

    Ingredient + strength + dose form. These are the concepts real FDA products actually carry.

Showing up to 8 concepts per family — 23 of 44 stored related concepts drawn.
These are official RxNorm vocabulary relationships — how concepts name and organize the same medicine. They do not establish therapeutic equivalence or substitutability: two concepts appearing in one web is never a statement that products can be swapped.

🔀 Generic ⇄ Brand Crosswalk

The same medicine has an unbranded (generic) identity and one or more brand-name identities — each with its own RxCUI. This is a naming relationship in RxNorm, not a statement that any two products are substitutable.

Generic (Clinical) Concepts

  • Isotretinoin 40 MG SCDC · 316110
  • Isotretinoin Oral Capsule SCDF · 370721
  • Isotretinoin Oral Product SCDG · 1159761
  • Isotretinoin Pill SCDG · 1159762

Brand-Name Concepts

📦 FDA Products & Package NDCs

84 products · 91 package NDCs
91 package NDCs map to RxCUI 197845 in the current snapshot — up to 50 per page. Each linked NDC opens its full package page.
Package NDC Package Brand / generic name Labeler Marketing start
00245-0575-01 3 BLISTER PACK in 1 BOX (0245-0575-01) / 10 CAPSULE, LIQUID... Isotretinoin Upsher-Smith Laboratories, LLC 2021-06-25
00378-6611-93 3 BLISTER PACK in 1 CARTON (0378-6611-93) / 10 CAPSULE in 1... Amnesteem Mylan Pharmaceuticals Inc. 2002-11-11
00378-6612-93 3 BLISTER PACK in 1 CARTON (0378-6612-93) / 10 CAPSULE in 1... Amnesteem Mylan Pharmaceuticals Inc. 2002-11-11
00378-6613-93 3 BLISTER PACK in 1 CARTON (0378-6613-93) / 10 CAPSULE in 1... Amnesteem Mylan Pharmaceuticals Inc. 2025-04-10
00378-6614-93 3 BLISTER PACK in 1 CARTON (0378-6614-93) / 10 CAPSULE in 1... Amnesteem Mylan Pharmaceuticals Inc. 2002-11-11
00555-1054-56 10 BLISTER PACK in 1 CARTON (0555-1054-56) / 10 CAPSULE, LI... Claravis Teva Pharmaceuticals USA, Inc. 2003-05-09
00555-1054-86 3 BLISTER PACK in 1 CARTON (0555-1054-86) / 10 CAPSULE, LIQ... Claravis Teva Pharmaceuticals USA, Inc. 2003-05-09
00555-1055-56 10 BLISTER PACK in 1 CARTON (0555-1055-56) / 10 CAPSULE, LI... Claravis Teva Pharmaceuticals USA, Inc. 2003-05-09
00555-1055-86 3 BLISTER PACK in 1 CARTON (0555-1055-86) / 10 CAPSULE, LIQ... Claravis Teva Pharmaceuticals USA, Inc. 2003-05-09
00555-1056-86 3 BLISTER PACK in 1 CARTON (0555-1056-86) / 10 CAPSULE, LIQ... Claravis Teva Pharmaceuticals USA, Inc. 2006-05-18
00555-1057-56 10 BLISTER PACK in 1 CARTON (0555-1057-56) / 10 CAPSULE, LI... Claravis Teva Pharmaceuticals USA, Inc. 2003-05-09
00555-1057-86 3 BLISTER PACK in 1 CARTON (0555-1057-86) / 10 CAPSULE, LIQ... Claravis Teva Pharmaceuticals USA, Inc. 2003-05-09
00591-2433-15 3 BLISTER PACK in 1 CARTON (0591-2433-15) / 10 CAPSULE in 1... Isotretinoin Actavis Pharma, Inc. 2021-04-29
00591-2434-15 3 BLISTER PACK in 1 CARTON (0591-2434-15) / 10 CAPSULE in 1... Isotretinoin Actavis Pharma, Inc. 2021-04-29
00591-2435-15 3 BLISTER PACK in 1 CARTON (0591-2435-15) / 10 CAPSULE in 1... Isotretinoin Actavis Pharma, Inc. 2021-04-29
00591-2436-15 3 BLISTER PACK in 1 CARTON (0591-2436-15) / 10 CAPSULE in 1... Isotretinoin Actavis Pharma, Inc. 2021-04-29
00591-2451-15 3 BLISTER PACK in 1 CARTON (0591-2451-15) / 10 CAPSULE in 1... Isotretinoin Actavis Pharma, Inc. 2021-04-29
00591-2501-15 3 BLISTER PACK in 1 CARTON (0591-2501-15) / 10 CAPSULE in 1... Isotretinoin Actavis Pharma, Inc. 2021-04-29
00832-8301-30 3 BLISTER PACK in 1 BOX (0832-8301-30) / 10 CAPSULE, LIQUID... Isotretinoin Upsher-Smith Laboratories, LLC 2023-06-06
00832-8302-30 3 BLISTER PACK in 1 BOX (0832-8302-30) / 10 CAPSULE, LIQUID... Isotretinoin Upsher-Smith Laboratories, LLC 2023-06-06
00832-8303-30 3 BLISTER PACK in 1 BOX (0832-8303-30) / 10 CAPSULE, LIQUID... Isotretinoin Upsher-Smith Laboratories, LLC 2023-06-06
00832-8304-30 3 BLISTER PACK in 1 BOX (0832-8304-30) / 10 CAPSULE, LIQUID... Isotretinoin Upsher-Smith Laboratories, LLC 2023-06-06
10631-0002-31 3 BLISTER PACK in 1 BOX (10631-002-31) / 10 CAPSULE in 1 BL... Absorica LD Sun Pharmaceutical Industries, Inc. 2019-11-20
10631-0003-31 3 BLISTER PACK in 1 BOX (10631-003-31) / 10 CAPSULE in 1 BL... Absorica LD Sun Pharmaceutical Industries, Inc. 2019-11-20
10631-0005-31 3 BLISTER PACK in 1 BOX (10631-005-31) / 10 CAPSULE in 1 BL... Absorica LD Sun Pharmaceutical Industries, Inc. 2019-11-20
10631-0007-31 3 BLISTER PACK in 1 BOX (10631-007-31) / 10 CAPSULE in 1 BL... Absorica LD Sun Pharmaceutical Industries, Inc. 2019-11-20
10631-0115-31 3 BLISTER PACK in 1 BOX (10631-115-31) / 10 CAPSULE in 1 BL... Absorica Sun Pharmaceutical Industries, Inc. 2012-06-08
10631-0116-31 3 BLISTER PACK in 1 BOX (10631-116-31) / 10 CAPSULE in 1 BL... Absorica Sun Pharmaceutical Industries, Inc. 2012-06-08
10631-0117-31 3 BLISTER PACK in 1 BOX (10631-117-31) / 10 CAPSULE in 1 BL... Absorica Sun Pharmaceutical Industries, Inc. 2012-06-08
10631-0118-31 3 BLISTER PACK in 1 BOX (10631-118-31) / 10 CAPSULE in 1 BL... Absorica Sun Pharmaceutical Industries, Inc. 2012-06-08
10631-0133-31 3 BLISTER PACK in 1 BOX (10631-133-31) / 10 CAPSULE in 1 BL... Absorica Sun Pharmaceutical Industries, Inc. 2015-02-17
10631-0134-31 3 BLISTER PACK in 1 BOX (10631-134-31) / 10 CAPSULE in 1 BL... Absorica Sun Pharmaceutical Industries, Inc. 2015-02-17
55111-0113-78 10 BLISTER PACK in 1 CARTON (55111-113-78) / 10 CAPSULE, GE... ZENATANE Dr. Reddy's Laboratories Limited 2015-03-09
55111-0113-81 3 BLISTER PACK in 1 CARTON (55111-113-81) / 10 CAPSULE, GEL... ZENATANE Dr. Reddy's Laboratories Limited 2015-03-09
55111-0135-81 3 BLISTER PACK in 1 CARTON (55111-135-81) / 10 CAPSULE, GEL... ZENATANE Dr. Reddy's Laboratories Limited 2013-03-26
55111-0136-81 3 BLISTER PACK in 1 CARTON (55111-136-81) / 10 CAPSULE, GEL... ZENATANE Dr. Reddy's Laboratories Limited 2013-03-26
55111-0137-81 3 BLISTER PACK in 1 CARTON (55111-137-81) / 10 CAPSULE, GEL... ZENATANE Dr. Reddy's Laboratories Limited 2013-03-26
57664-0020-97 3 BLISTER PACK in 1 BOX (57664-020-97) / 10 CAPSULE in 1 BL... Isotretinoin Sun Pharmaceutical Industries, Inc. 2020-12-29
57664-0021-97 3 BLISTER PACK in 1 BOX (57664-021-97) / 10 CAPSULE in 1 BL... Isotretinoin Sun Pharmaceutical Industries, Inc. 2020-12-29
57664-0022-97 3 BLISTER PACK in 1 BOX (57664-022-97) / 10 CAPSULE in 1 BL... Isotretinoin Sun Pharmaceutical Industries, Inc. 2020-12-29
57664-0023-97 3 BLISTER PACK in 1 BOX (57664-023-97) / 10 CAPSULE in 1 BL... Isotretinoin Sun Pharmaceutical Industries, Inc. 2020-12-29
57664-0024-97 3 BLISTER PACK in 1 BOX (57664-024-97) / 10 CAPSULE in 1 BL... Isotretinoin Sun Pharmaceutical Industries, Inc. 2020-12-29
57664-0025-97 3 BLISTER PACK in 1 BOX (57664-025-97) / 10 CAPSULE in 1 BL... Isotretinoin Sun Pharmaceutical Industries, Inc. 2020-12-29
59651-0631-03 3 BLISTER PACK in 1 CARTON (59651-631-03) / 10 CAPSULE in 1... ISOTRETINOIN Aurobindo Pharma Limited 2024-01-29
59651-0632-03 3 BLISTER PACK in 1 CARTON (59651-632-03) / 10 CAPSULE in 1... ISOTRETINOIN Aurobindo Pharma Limited 2024-01-29
59651-0633-03 3 BLISTER PACK in 1 CARTON (59651-633-03) / 10 CAPSULE in 1... ISOTRETINOIN Aurobindo Pharma Limited 2024-01-29
59651-0634-03 3 BLISTER PACK in 1 CARTON (59651-634-03) / 10 CAPSULE in 1... ISOTRETINOIN Aurobindo Pharma Limited 2024-01-29
59651-0635-03 3 BLISTER PACK in 1 CARTON (59651-635-03) / 10 CAPSULE in 1... ISOTRETINOIN Aurobindo Pharma Limited 2024-01-29
59651-0636-03 3 BLISTER PACK in 1 CARTON (59651-636-03) / 10 CAPSULE in 1... ISOTRETINOIN Aurobindo Pharma Limited 2024-01-29
68001-0652-17 3 BLISTER PACK in 1 CARTON (68001-652-17) / 10 CAPSULE, GEL... ZENATANE BluePoint Laboratories 2025-12-30
Observed labelers: Sun Pharmaceutical Industries, Inc. (16) · Zydus Lifesciences Limited (13) · Amneal Pharmaceuticals NY LLC (10) · Teva Pharmaceuticals USA, Inc. (7) · Actavis Pharma, Inc. (6) · Aurobindo Pharma Limited (6) · +7 more — this is the FDA-listed mapping footprint, not sales, inventory, availability, or market share.

🗃️ Sources & Limits

Atlas generation902fddb9-e9c1-4004-bf4c-dba4d51037c7
openFDA export observedJul 14, 2026
RxNorm release07/06/2026
Methodology2026-07-full-catalog-v1
  • A shared RxCUI does not prove interchangeability. Products mapped to the same concept are not thereby equivalent or substitutable — equivalence is a separate, product-level determination.
  • Listing here does not establish approval or coverage. Appearing in this snapshot is a data observation, not an FDA approval status or a payer coverage decision.
  • Missing data never means zero. A silent dataset (no price, no billing code, no utilization) means no observation — not that the real-world value is zero.
  • Counts describe the mapping footprint. Product, package, and labeler counts are the FDA-listed mapping footprint in this snapshot — not sales, inventory, availability, or market share.
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.

Machine-readable JSON

Reference information about drug-concept identifiers and public regulatory data — not medical advice. Talk to your pharmacist or prescriber about your own medication.