Home NDC 0074-2320 Rinvoq
Product NDC 0074-2320
11-digit product format 000742320
Labeler code 0074
Product ID 0074-2320_6c4bad0a-5930-4bb7-8509-6a8c6f279082
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Upadacitinib
Dosage form SOLUTION
Route ORAL
Labeler AbbVie Inc.
Application NDA218347
Marketing category NDA
Marketing start 2024-04-26
Substance UPADACITINIB
Active strength 1 mg/mL
Pharmacologic classes Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218347-001 RINVOQ LQ UPADACITINIB 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26
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 N218347-001 8962629 2031-01-15 U-3945 Drug substance 2024-05-23 N218347-001 8962629 2031-01-15 U-3946 Drug substance 2024-05-23 N218347-001 RE47221 2033-08-16 Drug substance 2024-06-12 N218347-001 10981923 2036-10-17 Drug substance 2024-05-23 N218347-001 11186584 2036-10-17 Drug substance 2024-05-23 N218347-001 11661425 2036-10-17 Drug substance 2024-05-23 N218347-001 11680069 2036-10-17 Drug substance 2024-05-23 N218347-001 11718627 2036-10-17 Drug substance 2024-05-23 N218347-001 11773105 2036-10-17 Drug substance 2024-05-23 N218347-001 12110298 2036-10-17 Drug substance 2024-11-05 N218347-001 12365689 2036-10-17 U-3945 2025-08-20 N218347-001 9951080 2036-10-17 Drug substance 2024-05-23
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218347-001 NP 2027-04-26 N218347-001 ODE-481 2031-04-26
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.
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 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218347-001 RINVOQ LQ 1MG/ML SOLUTION / ORAL RLD, RS 2024-04-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 143 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 N218347-001 8962629 2031-01-15 U-3946 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 8962629 2031-01-15 U-3945 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 RE47221 2033-08-16 Drug substance 2024-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 10981923 2036-10-17 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 11186584 2036-10-17 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 11661425 2036-10-17 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 11680069 2036-10-17 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 11718627 2036-10-17 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 11773105 2036-10-17 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 12110298 2036-10-17 Drug substance 2024-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 12365689 2036-10-17 U-3945 2025-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218347-001 9951080 2036-10-17 Drug substance 2024-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 8962629 2031-01-15 U-3946 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 8962629 2031-01-15 U-3945 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 RE47221 2033-08-16 Drug substance 2024-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 10981923 2036-10-17 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 11186584 2036-10-17 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 11661425 2036-10-17 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 11680069 2036-10-17 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 11718627 2036-10-17 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 11773105 2036-10-17 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 12110298 2036-10-17 Drug substance 2024-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 12365689 2036-10-17 U-3945 2025-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218347-001 9951080 2036-10-17 Drug substance 2024-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218347-001 8962629 2031-01-15 U-3946 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218347-001 8962629 2031-01-15 U-3945 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218347-001 RE47221 2033-08-16 Drug substance 2024-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218347-001 10981923 2036-10-17 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218347-001 11186584 2036-10-17 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218347-001 11661425 2036-10-17 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218347-001 11680069 2036-10-17 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218347-001 11718627 2036-10-17 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218347-001 11773105 2036-10-17 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218347-001 12110298 2036-10-17 Drug substance 2024-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218347-001 9951080 2036-10-17 Drug substance 2024-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218347-001 8962629 2031-01-15 U-3946 Drug substance 2024-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218347-001 8962629 2031-01-15 U-3945 Drug substance 2024-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218347-001 RE47221 2033-08-16 Drug substance 2024-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218347-001 10981923 2036-10-17 Drug substance 2024-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218347-001 11186584 2036-10-17 Drug substance 2024-05-23 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Rinvoq
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength UPADACITINIB 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4RA0KN46E0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2196894 Internal RxNorm lookup 2196900 Internal RxNorm lookup 2590051 Internal RxNorm lookup 2590054 Internal RxNorm lookup 2596957 Internal RxNorm lookup 2596960 Internal RxNorm lookup 2681015 Internal RxNorm lookup 2681019 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-2320 RINVOQ (UPADACITINIB) TABLET, EXTENDED RELEASE RINVOQ (UPADACITINIB) SOLUTION [ABBVIE INC.] 92 Current NDC, 4 package rows 20250501_2966aec7-2ef0-923c-d8ff-fe1a957bf095.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 Sample Exclude flag Status 0074-2320-01 00074232001 1 BOTTLE in 1 CARTON (0074-2320-01) / 180 mL in 1 BOTTLE 1 bottle 2024-04-26 No No Current 0074-2320-70 00074232070 1 BOTTLE in 1 CARTON (0074-2320-70) / 180 mL in 1 BOTTLE 1 bottle 2024-04-26 Yes No Current