Home NDC 58468-0211-2 Aubagio
Product NDC 58468-0211
Requested package NDC 58468-0211-2
11-digit product format 584680211
Labeler code 58468
Product ID 58468-0211_fafc0928-a014-4dfc-8f46-e0d8aa6690bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name teriflunomide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Genzyme Corporation
Application NDA202992
Marketing category NDA
Marketing start 2013-05-01
Substance TERIFLUNOMIDE
Active strength 7 mg/1
Pharmacologic classes Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202992-001 AUBAGIO TERIFLUNOMIDE 7MG TABLET / ORAL AB RLD 2012-09-12 N202992-002 AUBAGIO TERIFLUNOMIDE 14MG TABLET / ORAL AB RLD, RS 2012-09-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202992-001 6794410 2026-09-12 U-1285 2013-08-20 N202992-001 6794410*PED 2027-03-12 Pediatric extension N202992-001 8802735 2030-09-14 Drug product 2014-09-11 N202992-001 8802735*PED 2031-03-14 Pediatric extension N202992-001 9186346 2034-02-04 U-1786 2015-12-15 N202992-001 9186346*PED 2034-08-04 Pediatric extension N202992-002 6794410 2026-09-12 U-1285 2013-08-20 N202992-002 6794410*PED 2027-03-12 Pediatric extension N202992-002 8802735 2030-09-14 Drug product 2014-09-11 N202992-002 8802735*PED 2031-03-14 Pediatric extension N202992-002 9186346 2034-02-04 U-1786 2015-12-15 N202992-002 9186346*PED 2034-08-04 Pediatric extension
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 · 82 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 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202992-001 AUBAGIO 7MG TABLET / ORAL AB RLD 2012-09-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202992-002 AUBAGIO 14MG TABLET / ORAL AB RLD, RS 2012-09-12 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 12 · 444 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202992-001 6794410 2026-09-12 U-1285 2013-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-001 6794410*PED 2027-03-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-001 8802735 2030-09-14 Drug product 2014-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-001 8802735*PED 2031-03-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-001 9186346 2034-02-04 U-1786 2015-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-001 9186346*PED 2034-08-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 6794410 2026-09-12 U-1285 2013-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 6794410*PED 2027-03-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 8802735 2030-09-14 Drug product 2014-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 8802735*PED 2031-03-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 9186346 2034-02-04 U-1786 2015-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202992-002 9186346*PED 2034-08-04 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 6794410 2026-09-12 U-1285 2013-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 6794410*PED 2027-03-12 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 8802735 2030-09-14 Drug product 2014-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 8802735*PED 2031-03-14 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 9186346 2034-02-04 U-1786 2015-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-001 9186346*PED 2034-08-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 6794410 2026-09-12 U-1285 2013-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 6794410*PED 2027-03-12 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 8802735 2030-09-14 Drug product 2014-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 8802735*PED 2031-03-14 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 9186346 2034-02-04 U-1786 2015-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202992-002 9186346*PED 2034-08-04 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202992-001 6794410 2026-09-12 U-1285 2013-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-001 6794410*PED 2027-03-12 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-001 8802735 2030-09-14 Drug product 2014-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-001 8802735*PED 2031-03-14 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-001 9186346 2034-02-04 U-1786 2015-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-001 9186346*PED 2034-08-04 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 6794410 2026-09-12 U-1285 2013-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 6794410*PED 2027-03-12 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 8802735 2030-09-14 Drug product 2014-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 8802735*PED 2031-03-14 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 9186346 2034-02-04 U-1786 2015-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202992-002 9186346*PED 2034-08-04 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-001 6794410 2026-09-12 U-1285 2013-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-001 6794410*PED 2027-03-12 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-001 8802735 2030-09-14 Drug product 2014-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202992-001 8802735*PED 2031-03-14 Pediatric extension fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 108 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Aubagio
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERIFLUNOMIDE 7 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1C058IKG3B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1310525 Internal RxNorm lookup 1310531 Internal RxNorm lookup 1310533 Internal RxNorm lookup 1310535 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 58468-0211-1 Aubagio 14 in 1 BLISTER PACK TABLET, FILM COATED 14 28 58468-0211-1 Aubagio 2 in 1 CARTON TABLET, FILM COATED 2 28 58468-0211-2 Aubagio 5 in 1 BLISTER PACK TABLET, FILM COATED 5 28 58468-0211-2 Aubagio 1 in 1 CARTON TABLET, FILM COATED 1 28 58468-0211-3 Aubagio 5 in 1 BLISTER PACK TABLET, FILM COATED 5 28 58468-0211-3 Aubagio 1 in 1 CARTON TABLET, FILM COATED 1 28 58468-0211-4 Aubagio 30 in 1 BOTTLE TABLET, FILM COATED 30 28 58468-0211-4 Aubagio 1 in 1 CARTON TABLET, FILM COATED 1 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded teriflunomide ACTIVE INGREDIENT 1C058IKG3B AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 teriflunomide ACTIVE MOIETY 1C058IKG3B AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 FD&C blue no. 2 INACTIVE INGREDIENT L06K8R7DQK AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 sodium starch glycolate type a corn INACTIVE INGREDIENT AG9B65PV6B AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 starch, corn INACTIVE INGREDIENT O8232NY3SJ AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 talc INACTIVE INGREDIENT 7SEV7J4R1U AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-0211 AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORPORATION] 27 Current NDC, Legacy NDC, 8 package rows 20240627_4650d12c-b9c8-4525-b07f-a2d773eca155.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.
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 58468-0211-2 58468021102 1 BLISTER PACK in 1 CARTON (58468-0211-2) / 5 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2013-05-01 0000-00-00 No No Current