Home NDC 0074-7096 Qulipta
Product NDC 0074-7096
11-digit product format 000747096
Labeler code 0074
Product ID 0074-7096_392c0320-ca25-423a-9bc1-d06f6badab07
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atogepant
Dosage form TABLET
Route ORAL
Labeler AbbVie Inc.
Application NDA215206
Marketing category NDA
Marketing start 2021-09-30
Substance ATOGEPANT
Active strength 30 mg/1
Pharmacologic classes Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [MoA]
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 42 .
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 N215206-001 QULIPTA ATOGEPANT 10MG TABLET / ORAL RLD 2021-09-28 N215206-002 QULIPTA ATOGEPANT 30MG TABLET / ORAL RLD 2021-09-28 N215206-003 QULIPTA ATOGEPANT 60MG TABLET / ORAL RLD, RS 2021-09-28
Orange Book patents# Current patent rows page 1 of 1 · 22 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215206-001 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 N215206-001 9850246 2033-03-13 Drug substance 2021-10-26 N215206-001 10117836 2035-01-30 Drug product 2021-10-26 N215206-001 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 N215206-001 12383545 2039-06-06 U-3534 2025-09-09 N215206-001 12090148 2041-07-29 U-3534 2025-09-09 N215206-001 12465598 2042-09-27 U-4355 2025-12-10 N215206-001 12622897 2042-09-27 U-4536 2026-06-09 N215206-001 12350259 2043-02-27 U-4234 2025-08-06 N215206-002 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 N215206-002 9850246 2033-03-13 Drug substance 2021-10-26 N215206-002 10117836 2035-01-30 Drug product 2021-10-26 N215206-002 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 N215206-002 12383545 2039-06-06 U-3534 2025-09-09 N215206-002 12090148 2041-07-29 U-3534 2025-09-09 N215206-002 12622897 2042-09-27 U-4536 2026-06-09 N215206-003 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 N215206-003 9850246 2033-03-13 Drug substance 2021-10-26 N215206-003 10117836 2035-01-30 Drug product 2021-10-26 N215206-003 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 N215206-003 12383545 2039-06-06 U-3534 2025-09-09 N215206-003 12090148 2041-07-29 U-3534 2024-10-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 3 · 102 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 2026-08-18 06:07:40 2026-07 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215206-002 QULIPTA 30MG TABLET / ORAL RLD 2021-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215206-003 QULIPTA 60MG TABLET / ORAL RLD, RS 2021-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215206-001 QULIPTA 10MG TABLET / ORAL RLD 2021-09-28 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 12 · 451 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215206-001 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 9850246 2033-03-13 Drug substance 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 10117836 2035-01-30 Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 12383545 2039-06-06 U-3534 2025-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 12090148 2041-07-29 U-3534 2025-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 12465598 2042-09-27 U-4355 2025-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 12622897 2042-09-27 U-4536 2026-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-001 12350259 2043-02-27 U-4234 2025-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 9850246 2033-03-13 Drug substance 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 10117836 2035-01-30 Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 12383545 2039-06-06 U-3534 2025-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 12090148 2041-07-29 U-3534 2025-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-002 12622897 2042-09-27 U-4536 2026-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 9850246 2033-03-13 Drug substance 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 10117836 2035-01-30 Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 8754096 2035-09-28 U-3534 Drug substance, Drug product 2021-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 12383545 2039-06-06 U-3534 2025-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215206-003 12090148 2041-07-29 U-3534 2024-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215206-001 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 8754096 2032-07-19 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 9850246 2033-03-13 Drug substance 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 10117836 2035-01-30 Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 12383545 2039-06-06 U-3534 2025-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 12090148 2041-07-29 U-3534 2025-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 12465598 2042-09-27 U-4355 2025-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-001 12350259 2043-02-27 U-4234 2025-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 8754096 2032-07-19 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 9850246 2033-03-13 Drug substance 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 10117836 2035-01-30 Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 12383545 2039-06-06 U-3534 2025-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-002 12090148 2041-07-29 U-3534 2025-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-003 9499545 2031-11-10 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-003 8754096 2032-07-19 U-3534 Drug substance, Drug product 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-003 9850246 2033-03-13 Drug substance 2021-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215206-003 10117836 2035-01-30 Drug product 2021-10-26 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 171 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Qulipta
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATOGEPANT 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7CRV8RR151 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2571836 Internal RxNorm lookup 2571842 Internal RxNorm lookup 2571844 Internal RxNorm lookup 2571846 Internal RxNorm lookup 2571848 Internal RxNorm lookup 2571850 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 0074-7096-04 Qulipta 4 in 1 BOTTLE TABLET 4 19 0074-7096-30 Qulipta 30 in 1 BOTTLE TABLET 30 19 0074-7096-70 Qulipta 4 in 1 BOTTLE TABLET 4 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-7096 QULIPTA (ATOGEPANT) TABLET [ABBVIE INC.] 15 Current NDC, Legacy NDC, 3 package rows 20250330_8c8ab8f4-32bd-497a-befa-70c8a51d8d52.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 0074-7096-04 00074709604 4 TABLET in 1 BOTTLE (0074-7096-04) 4 tablet 2021-10-06 0000-00-00 Yes No Current 0074-7096-30 00074709630 30 TABLET in 1 BOTTLE (0074-7096-30) 30 tablet 2021-09-30 0000-00-00 No No Current 0074-7096-70 00074709670 4 TABLET in 1 BOTTLE (0074-7096-70) 4 tablet 2026-02-06 Yes No Current