FDA.reportPublic FDA data

ISOTRETINOIN

Product NDC
59651-635
11-digit product format
596510635
Labeler code
59651
Product ID
59651-635_4f6cfc86-c6ad-413a-baf6-5df2b0cb3511
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISOTRETINOIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218194
Marketing category
ANDA
Marketing start
2024-01-29
Substance
ISOTRETINOIN
Active strength
35 mg/1
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218194-001ISOTRETINOINISOTRETINOIN10MGCAPSULE / ORALAB22024-01-29
A218194-002ISOTRETINOINISOTRETINOIN20MGCAPSULE / ORALAB22024-01-29
A218194-003ISOTRETINOINISOTRETINOIN25MGCAPSULE / ORALAB22024-01-29
A218194-004ISOTRETINOINISOTRETINOIN30MGCAPSULE / ORALAB22024-01-29
A218194-005ISOTRETINOINISOTRETINOIN35MGCAPSULE / ORALAB22024-01-29
A218194-006ISOTRETINOINISOTRETINOIN40MGCAPSULE / ORALAB22024-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A218194-001AB2
A218194-002AB2
A218194-003AB2
A218194-004AB2
A218194-005AB2
A218194-006AB2

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A218194-001ISOTRETINOIN10MGCAPSULE / ORALAB22024-01-29c2088c7a36db…
2026-10-15 13:18:302026-09A218194-002ISOTRETINOIN20MGCAPSULE / ORALAB22024-01-29c2088c7a36db…
2026-10-15 13:18:302026-09A218194-003ISOTRETINOIN25MGCAPSULE / ORALAB22024-01-29c2088c7a36db…
2026-10-15 13:18:302026-09A218194-004ISOTRETINOIN30MGCAPSULE / ORALAB22024-01-29c2088c7a36db…
2026-10-15 13:18:302026-09A218194-005ISOTRETINOIN35MGCAPSULE / ORALAB22024-01-29c2088c7a36db…
2026-10-15 13:18:302026-09A218194-006ISOTRETINOIN40MGCAPSULE / ORALAB22024-01-29c2088c7a36db…
2026-09-14 22:38:342026-08A218194-001ISOTRETINOIN10MGCAPSULE / ORALAB22024-01-2984e616aacf4f…
2026-09-14 22:38:342026-08A218194-002ISOTRETINOIN20MGCAPSULE / ORALAB22024-01-2984e616aacf4f…
2026-09-14 22:38:342026-08A218194-003ISOTRETINOIN25MGCAPSULE / ORALAB22024-01-2984e616aacf4f…
2026-09-14 22:38:342026-08A218194-004ISOTRETINOIN30MGCAPSULE / ORALAB22024-01-2984e616aacf4f…
2026-09-14 22:38:342026-08A218194-005ISOTRETINOIN35MGCAPSULE / ORALAB22024-01-2984e616aacf4f…
2026-09-14 22:38:342026-08A218194-006ISOTRETINOIN40MGCAPSULE / ORALAB22024-01-2984e616aacf4f…
2026-08-18 06:07:402026-07A218194-001ISOTRETINOIN10MGCAPSULE / ORALAB22024-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A218194-002ISOTRETINOIN20MGCAPSULE / ORALAB22024-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A218194-003ISOTRETINOIN25MGCAPSULE / ORALAB22024-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A218194-004ISOTRETINOIN30MGCAPSULE / ORALAB22024-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A218194-005ISOTRETINOIN35MGCAPSULE / ORALAB22024-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A218194-006ISOTRETINOIN40MGCAPSULE / ORALAB22024-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218194-001ISOTRETINOIN10MGCAPSULE / ORALAB22024-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218194-002ISOTRETINOIN20MGCAPSULE / ORALAB22024-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218194-003ISOTRETINOIN25MGCAPSULE / ORALAB22024-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218194-004ISOTRETINOIN30MGCAPSULE / ORALAB22024-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218194-005ISOTRETINOIN35MGCAPSULE / ORALAB22024-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218194-006ISOTRETINOIN40MGCAPSULE / ORALAB22024-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218194-001ISOTRETINOIN10MGCAPSULE / ORALAB22024-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218194-002ISOTRETINOIN20MGCAPSULE / ORALAB22024-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218194-003ISOTRETINOIN25MGCAPSULE / ORALAB22024-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218194-004ISOTRETINOIN30MGCAPSULE / ORALAB22024-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218194-005ISOTRETINOIN35MGCAPSULE / ORALAB22024-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218194-006ISOTRETINOIN40MGCAPSULE / ORALAB22024-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A218194-001ISOTRETINOIN10MGCAPSULE / ORALAB22024-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218194-002ISOTRETINOIN20MGCAPSULE / ORALAB22024-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218194-003ISOTRETINOIN25MGCAPSULE / ORALAB22024-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218194-004ISOTRETINOIN30MGCAPSULE / ORALAB22024-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218194-005ISOTRETINOIN35MGCAPSULE / ORALAB22024-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218194-006ISOTRETINOIN40MGCAPSULE / ORALAB22024-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218194-001ISOTRETINOIN10MGCAPSULE / ORALAB22024-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218194-002ISOTRETINOIN20MGCAPSULE / ORALAB22024-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218194-003ISOTRETINOIN25MGCAPSULE / ORALAB22024-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218194-004ISOTRETINOIN30MGCAPSULE / ORALAB22024-01-29fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218194-005AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218194-006AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218194-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218194-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218194-003AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218194-004AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218194-005AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218194-006AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218194-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218194-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218194-003AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218194-004AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218194-005AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218194-006AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218194-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218194-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218194-003AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218194-004AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218194-005AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218194-006AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218194-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218194-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218194-003AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218194-004AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218194-005AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218194-006AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218194-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218194-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218194-003AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218194-004AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218194-005AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218194-006AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218194-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A218194-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A218194-003AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A218194-004AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A218194-005AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A218194-006AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218194-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218194-002AB2179d66fd596c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ISOTRETINOIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOTRETINOIN35 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8300c0f6-79a4-735b-88ec-d781bfffdb10Product name520260305
644afe93-ba9b-4043-8e40-a9fe9af2d5d7Product name220250616
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
e5fedfa5-6b96-4769-872b-95d1e7f3a85aProduct name120200415
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-635-03ISOTRETINOIN10 in 1 BLISTER PACKCAPSULE103
59651-635-03ISOTRETINOIN3 in 1 CARTONCAPSULE33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-635-03EA - Each59651-63574722d43-7f34-4b9a-8234-b4cd515497e012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-635ISOTRETINOIN CAPSULE [AUROBINDO PHARMA LIMITED]2Current NDC, 2 package rows20241103_4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197843ISOtretinoin 10 MG Oral CapsulePSN4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
197844ISOtretinoin 20 MG Oral CapsulePSN4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
1547561ISOtretinoin 25 MG Oral CapsulePSN4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
403930ISOtretinoin 30 MG Oral CapsulePSN4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
1547565ISOtretinoin 35 MG Oral CapsulePSN4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
197845ISOtretinoin 40 MG Oral CapsulePSN4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
197843isotretinoin 10 MG Oral CapsuleSCD4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
197844isotretinoin 20 MG Oral CapsuleSCD4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
1547561isotretinoin 25 MG Oral CapsuleSCD4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
403930isotretinoin 30 MG Oral CapsuleSCD4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
1547565isotretinoin 35 MG Oral CapsuleSCD4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63
197845isotretinoin 40 MG Oral CapsuleSCD4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-635-03596510635033 BLISTER PACK in 1 CARTON (59651-635-03) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2024-01-29NoNoCurrent