Home NDC 0555-1057 Claravis
Product NDC 0555-1057
11-digit product format 005551057
Labeler code 0555
Product ID 0555-1057_a69dde5d-5585-4313-be43-02d11fec4c9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isotretinoin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076135
Marketing category ANDA
Marketing start 2003-05-09
Substance ISOTRETINOIN
Active strength 40 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076135-001 CLARAVIS ISOTRETINOIN 40MG CAPSULE / ORAL AB1 RS 2003-04-11 A076135-002 CLARAVIS ISOTRETINOIN 20MG CAPSULE / ORAL AB1 2003-04-11 A076135-003 CLARAVIS ISOTRETINOIN 30MG CAPSULE / ORAL AB1 2006-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076135-002 CLARAVIS 20MG CAPSULE / ORAL AB1 2003-04-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076135-003 CLARAVIS 30MG CAPSULE / ORAL AB1 2006-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076135-001 CLARAVIS 40MG CAPSULE / ORAL AB1 RS 2003-04-11 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Claravis
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOTRETINOIN 40 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 404059 Internal RxNorm lookup 404062 Internal RxNorm lookup 404065 Internal RxNorm lookup 643488 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 0555-1057-56 Claravis 10 in 1 CARTON CAPSULE, LIQUID FILLED 10 18 0555-1057-60 Claravis 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 18 0555-1057-86 Claravis 3 in 1 CARTON CAPSULE, LIQUID FILLED 3 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ISOTRETINOIN ACTIVE INGREDIENT EH28UP18IF CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 ISOTRETINOIN ACTIVE MOIETY EH28UP18IF CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 AMMONIA INACTIVE INGREDIENT 5138Q19F1X CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 COTTONSEED OIL INACTIVE INGREDIENT H3E878020N CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 D&C RED NO. 7 INACTIVE INGREDIENT ECW0LZ41X8 CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 ETHYLENE GLYCOL MONOETHYL ETHER INACTIVE INGREDIENT IDK7C2HS09 CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 GELATIN INACTIVE INGREDIENT 2G86QN327L CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 SHELLAC INACTIVE INGREDIENT 46N107B71O CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.] 8 ISOTRETINOIN ACTIVE INGREDIENT EH28UP18IF CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 ISOTRETINOIN ACTIVE MOIETY EH28UP18IF CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 AMMONIA INACTIVE INGREDIENT 5138Q19F1X CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 COTTONSEED OIL INACTIVE INGREDIENT H3E878020N CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 SHELLAC INACTIVE INGREDIENT 46N107B71O CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-1057 CLARAVIS (ISOTRETINOIN) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA, INC.] 18 Current NDC, Legacy NDC, 3 package rows 20220908_a31fd109-d0fd-4ab9-ba98-a3d64333c18d.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Claravis ISOTRETINOIN Teva Pharmaceuticals USA, Inc. a31fd109-d0fd-4ab9-ba98-a3d64333c18d 2022-08-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076135 application number: ANDA076135 ndc (product): 0555-1057
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 0555-1057-56 00555105756 10 BLISTER PACK in 1 CARTON (0555-1057-56) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1057-60) 10 blister pack 2003-05-09 0000-00-00 No No Current 0555-1057-60 00555105760 10 in 1 BLISTER PACK Historical 0555-1057-86 00555105786 3 BLISTER PACK in 1 CARTON (0555-1057-86) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1057-60) 3 blister pack 2003-05-09 0000-00-00 No No Current