Home NDC 0074-7098-03 VUITY
Product NDC 0074-7098
Requested package NDC 0074-7098-03
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 43 .
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 2026-09-14 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 · 162 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214028-001 11285134 2039-04-24 U-3562 2022-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214028-001 11285134 2039-04-24 U-3252 2022-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214028-001 10610518 2039-04-24 U-3562 2021-11-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214028-001 10610518 2039-04-24 U-3561 2021-11-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214028-001 10610518 2039-04-24 U-3252 2021-11-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214028-001 11285134 2039-04-24 U-3561 2022-04-28 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 51 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
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 0074-7098-03 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