Home NDC 68001-654 ZENATANE
Product NDC 68001-654
11-digit product format 680010654
Labeler code 68001
Product ID 68001-654_4e69c221-c1ba-9b55-e063-6394a90afbd4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ISOTRETINOIN
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler BluePoint Laboratories
Application ANDA202099
Marketing category ANDA
Marketing start 2025-12-23
Substance ISOTRETINOIN
Active strength 30 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 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202099-001 ZENATANE ISOTRETINOIN 10MG CAPSULE / ORAL AB1 2013-03-25 A202099-002 ZENATANE ISOTRETINOIN 20MG CAPSULE / ORAL AB1 2013-03-25 A202099-003 ZENATANE ISOTRETINOIN 40MG CAPSULE / ORAL AB1 2013-03-25 A202099-004 ZENATANE ISOTRETINOIN 30MG CAPSULE / ORAL AB1 2015-02-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A202099-001 ZENATANE 10MG CAPSULE / ORAL AB1 2013-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202099-002 ZENATANE 20MG CAPSULE / ORAL AB1 2013-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202099-003 ZENATANE 40MG CAPSULE / ORAL AB1 2013-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202099-004 ZENATANE 30MG CAPSULE / ORAL AB1 2015-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202099-001 ZENATANE 10MG CAPSULE / ORAL AB1 2013-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202099-002 ZENATANE 20MG CAPSULE / ORAL AB1 2013-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202099-003 ZENATANE 40MG CAPSULE / ORAL AB1 2013-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202099-004 ZENATANE 30MG CAPSULE / ORAL AB1 2015-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202099-001 ZENATANE 10MG CAPSULE / ORAL AB1 2013-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202099-002 ZENATANE 20MG CAPSULE / ORAL AB1 2013-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202099-003 ZENATANE 40MG CAPSULE / ORAL AB1 2013-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202099-004 ZENATANE 30MG CAPSULE / ORAL AB1 2015-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202099-001 ZENATANE 10MG CAPSULE / ORAL AB1 2013-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202099-002 ZENATANE 20MG CAPSULE / ORAL AB1 2013-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202099-003 ZENATANE 40MG CAPSULE / ORAL AB1 2013-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202099-004 ZENATANE 30MG CAPSULE / ORAL AB1 2015-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202099-001 ZENATANE 10MG CAPSULE / ORAL AB1 2013-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202099-002 ZENATANE 20MG CAPSULE / ORAL AB1 2013-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202099-003 ZENATANE 40MG CAPSULE / ORAL AB1 2013-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202099-004 ZENATANE 30MG CAPSULE / ORAL AB1 2015-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202099-001 ZENATANE 10MG CAPSULE / ORAL AB1 2013-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202099-002 ZENATANE 20MG CAPSULE / ORAL AB1 2013-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202099-003 ZENATANE 40MG CAPSULE / ORAL AB1 2013-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202099-004 ZENATANE 30MG CAPSULE / ORAL AB1 2015-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202099-001 ZENATANE 10MG CAPSULE / ORAL AB1 2013-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202099-002 ZENATANE 20MG CAPSULE / ORAL AB1 2013-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202099-003 ZENATANE 40MG CAPSULE / ORAL AB1 2013-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202099-004 ZENATANE 30MG CAPSULE / ORAL AB1 2015-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202099-001 ZENATANE 10MG CAPSULE / ORAL AB1 2013-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202099-002 ZENATANE 20MG CAPSULE / ORAL AB1 2013-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202099-003 ZENATANE 40MG CAPSULE / ORAL AB1 2013-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202099-004 ZENATANE 30MG CAPSULE / ORAL AB1 2015-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202099-001 ZENATANE 10MG CAPSULE / ORAL AB1 2013-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202099-002 ZENATANE 20MG CAPSULE / ORAL AB1 2013-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202099-003 ZENATANE 40MG CAPSULE / ORAL AB1 2013-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202099-004 ZENATANE 30MG CAPSULE / ORAL AB1 2015-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202099-001 ZENATANE 10MG CAPSULE / ORAL AB1 2013-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202099-002 ZENATANE 20MG CAPSULE / ORAL AB1 2013-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202099-003 ZENATANE 40MG CAPSULE / ORAL AB1 2013-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202099-004 ZENATANE 30MG CAPSULE / ORAL AB1 2015-02-23 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ZENATANE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOTRETINOIN 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH28UP18IF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197843 Internal RxNorm lookup 197844 Internal RxNorm lookup 197845 Internal RxNorm lookup 403930 Internal RxNorm lookup 1373333 Internal RxNorm lookup 1373335 Internal RxNorm lookup 1373337 Internal RxNorm lookup 1605088 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68001-654-16 ZENATANE 10 in 1 BLISTER PACK CAPSULE, GELATIN COATED 10 4 68001-654-17 ZENATANE 3 in 1 CARTON CAPSULE, GELATIN COATED 3 4
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68001-654-16 68001065416 10 in 1 BLISTER PACK Historical 68001-654-17 68001065417 3 BLISTER PACK in 1 CARTON (68001-654-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-654-16) 3 blister pack 2025-12-23 No No Current