Home NDC 55111-113 ZENATANE
Product NDC 55111-113
11-digit product format 551110113
Labeler code 55111
Product ID 55111-113_d7d883f9-7d20-2c50-8023-e661b46dcd5b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ISOTRETINOIN
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA202099
Marketing category ANDA
Marketing start 2015-03-09
Substance ISOTRETINOIN
Active strength 30 mg/1
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 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 55111-113-78 ZENATANE 10 in 1 CARTON CAPSULE, GELATIN COATED 10 27 55111-113-79 ZENATANE 10 in 1 BLISTER PACK CAPSULE, GELATIN COATED 10 27 55111-113-81 ZENATANE 3 in 1 CARTON CAPSULE, GELATIN COATED 3 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ISOTRETINOIN ACTIVE INGREDIENT EH28UP18IF ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 ISOTRETINOIN ACTIVE MOIETY EH28UP18IF ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 GELATIN INACTIVE INGREDIENT 2G86QN327L ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 HYDROGENATED SOYBEAN OIL INACTIVE INGREDIENT A2M91M918C ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 SHELLAC INACTIVE INGREDIENT 46N107B71O ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-113 ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED] 27 Current NDC, Legacy NDC, 3 package rows 20250210_27b3cf26-f22e-5b70-1c24-009933b7c6ee.zip
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 Marketing end Sample Exclude flag Status 55111-113-78 55111011378 10 BLISTER PACK in 1 CARTON (55111-113-78) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79) 10 blister pack 2015-03-09 0000-00-00 No No Current 55111-113-79 55111011379 10 in 1 BLISTER PACK Historical 55111-113-81 55111011381 3 BLISTER PACK in 1 CARTON (55111-113-81) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79) 3 blister pack 2015-03-09 0000-00-00 No No Current