Home NDC 0074-7098 VUITY
Product NDC 0074-7098
11-digit product format 000747098
Labeler code 0074
Product ID 0074-7098_584da1c7-0d0c-44d3-8a24-eac650f16450
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pilocarpine Hydrochloride
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler AbbVie Inc.
Application NDA214028
Marketing category NDA
Marketing start 2021-10-28
Marketing end 0000-00-00
Substance PILOCARPINE HYDROCHLORIDE
Active strength 13 mg/mL
Pharmacologic classes Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N214028-001 VUITY PILOCARPINE HYDROCHLORIDE 1.25% SOLUTION/DROPS / OPHTHALMIC RLD 2021-10-28
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214028-001 10610518 2039-04-24 U-3252 2021-11-24 N214028-001 10610518 2039-04-24 U-3561 2021-11-24 N214028-001 10610518 2039-04-24 U-3562 2021-11-24 N214028-001 11285134 2039-04-24 U-3252 2022-04-28 N214028-001 11285134 2039-04-24 U-3561 2022-04-28 N214028-001 11285134 2039-04-24 U-3562 2022-04-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214028-001 D-187 2026-03-28
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 2026-10-15 13:18:30 2026-09 N214028-001 VUITY 1.25% SOLUTION/DROPS / OPHTHALMIC RLD 2021-10-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N214028-001 VUITY 1.25% SOLUTION/DROPS / OPHTHALMIC RLD 2021-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214028-001 VUITY 1.25% SOLUTION/DROPS / OPHTHALMIC RLD 2021-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214028-001 VUITY 1.25% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2021-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214028-001 VUITY 1.25% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2021-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC AB RLD, RS 2021-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214028-001 VUITY 1.25% SOLUTION / OPHTHALMIC RLD, RS 2021-10-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214028-001 VUITY 1.25% SOLUTION/DROPS / OPHTHALMIC RLD 2021-10-28 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N214028-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214028-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214028-001 AB 1 6a471c1ec25d…
Observed Orange Book patent history# Patent history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N214028-001 10610518 2039-04-24 U-3562 2021-11-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214028-001 10610518 2039-04-24 U-3561 2021-11-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214028-001 10610518 2039-04-24 U-3252 2021-11-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214028-001 11285134 2039-04-24 U-3561 2022-04-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214028-001 11285134 2039-04-24 U-3562 2022-04-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214028-001 11285134 2039-04-24 U-3252 2022-04-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N214028-001 10610518 2039-04-24 U-3562 2021-11-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214028-001 10610518 2039-04-24 U-3561 2021-11-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214028-001 10610518 2039-04-24 U-3252 2021-11-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214028-001 11285134 2039-04-24 U-3561 2022-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214028-001 11285134 2039-04-24 U-3562 2022-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214028-001 11285134 2039-04-24 U-3252 2022-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214028-001 10610518 2039-04-24 U-3562 2021-11-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214028-001 10610518 2039-04-24 U-3561 2021-11-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214028-001 10610518 2039-04-24 U-3252 2021-11-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214028-001 11285134 2039-04-24 U-3561 2022-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214028-001 11285134 2039-04-24 U-3562 2022-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214028-001 11285134 2039-04-24 U-3252 2022-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214028-001 10610518 2039-04-24 U-3562 2021-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214028-001 10610518 2039-04-24 U-3561 2021-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214028-001 10610518 2039-04-24 U-3252 2021-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214028-001 11285134 2039-04-24 U-3561 2022-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214028-001 11285134 2039-04-24 U-3562 2022-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214028-001 11285134 2039-04-24 U-3252 2022-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214028-001 10610518 2039-04-24 U-3562 2021-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214028-001 10610518 2039-04-24 U-3561 2021-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214028-001 10610518 2039-04-24 U-3252 2021-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214028-001 11285134 2039-04-24 U-3561 2022-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214028-001 11285134 2039-04-24 U-3562 2022-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214028-001 11285134 2039-04-24 U-3252 2022-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214028-001 10610518 2039-04-24 U-3562 2021-11-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214028-001 10610518 2039-04-24 U-3561 2021-11-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214028-001 10610518 2039-04-24 U-3252 2021-11-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214028-001 11285134 2039-04-24 U-3561 2022-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214028-001 11285134 2039-04-24 U-3562 2022-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214028-001 11285134 2039-04-24 U-3252 2022-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214028-001 10610518 2039-04-24 U-3562 2021-11-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214028-001 10610518 2039-04-24 U-3561 2021-11-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214028-001 10610518 2039-04-24 U-3252 2021-11-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214028-001 11285134 2039-04-24 U-3561 2022-04-28 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 52 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-7098 VUITY (PILOCARPINE HYDROCHLORIDE) SOLUTION/ DROPS [ABBVIE INC.] 13 Legacy NDC, 8 package rows 20230404_8d806897-8a2a-4518-8c68-0ec3b778de50.zip
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 0074-7098-01 00074709801 1 BOTTLE in 1 BOX (0074-7098-01) > 5 mL in 1 BOTTLE 1 bottle 2021-10-28 0000-00-00 No No Current 0074-7098-02 00074709802 2.5 mL in 1 BOTTLE 2.5 ml Historical 0074-7098-03 00074709803 3 BOTTLE in 1 BOX (0074-7098-03) > 5 mL in 1 BOTTLE 3 bottle 2021-10-28 0000-00-00 No No Current 0074-7098-04 00074709804 1 BOTTLE in 1 CARTON (0074-7098-04) > 5 mL in 1 BOTTLE 1 bottle 2021-10-28 0000-00-00 No No Current 0074-7098-05 00074709805 1 BOTTLE in 1 CARTON (0074-7098-05) > 1.5 mL in 1 BOTTLE 1 bottle 2021-10-28 0000-00-00 Yes No Current 0074-7098-06 00074709806 5 mL in 1 BOTTLE 5 ml Historical