VUITY

Product NDC
0074-7098
Requested package NDC
0074-7098-04
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0074-70980074-7098-04DDiscontinued by firm2026-10-30

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214028-001VUITYPILOCARPINE HYDROCHLORIDE1.25%SOLUTION/DROPS / OPHTHALMICRLD2021-10-28

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214028-001106105182039-04-24U-32522021-11-24
N214028-001106105182039-04-24U-35612021-11-24
N214028-001106105182039-04-24U-35622021-11-24
N214028-001112851342039-04-24U-32522022-04-28
N214028-001112851342039-04-24U-35612022-04-28
N214028-001112851342039-04-24U-35622022-04-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N214028-001D-1872026-03-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N214028-001VUITY1.25%SOLUTION/DROPS / OPHTHALMICRLD2021-10-28c2088c7a36db…
2026-09-14 22:38:342026-08N214028-001VUITY1.25%SOLUTION/DROPS / OPHTHALMICRLD2021-10-2884e616aacf4f…
2026-08-18 06:07:402026-07N214028-001VUITY1.25%SOLUTION/DROPS / OPHTHALMICRLD2021-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214028-001VUITY1.25%SOLUTION/DROPS / OPHTHALMICABRLD, RS2021-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214028-001VUITY1.25%SOLUTION/DROPS / OPHTHALMICABRLD, RS2021-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N214028-001VUITY1.25%SOLUTION / OPHTHALMICABRLD, RS2021-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214028-001VUITY1.25%SOLUTION / OPHTHALMICRLD, RS2021-10-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214028-001VUITY1.25%SOLUTION/DROPS / OPHTHALMICRLD2021-10-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N214028-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214028-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N214028-001AB16a471c1ec25d…

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N214028-001106105182039-04-24U-35622021-11-24c2088c7a36db…
2026-10-15 13:18:302026-09N214028-001106105182039-04-24U-35612021-11-24c2088c7a36db…
2026-10-15 13:18:302026-09N214028-001106105182039-04-24U-32522021-11-24c2088c7a36db…
2026-10-15 13:18:302026-09N214028-001112851342039-04-24U-35612022-04-28c2088c7a36db…
2026-10-15 13:18:302026-09N214028-001112851342039-04-24U-35622022-04-28c2088c7a36db…
2026-10-15 13:18:302026-09N214028-001112851342039-04-24U-32522022-04-28c2088c7a36db…
2026-09-14 22:38:342026-08N214028-001106105182039-04-24U-35622021-11-2484e616aacf4f…
2026-09-14 22:38:342026-08N214028-001106105182039-04-24U-35612021-11-2484e616aacf4f…
2026-09-14 22:38:342026-08N214028-001106105182039-04-24U-32522021-11-2484e616aacf4f…
2026-09-14 22:38:342026-08N214028-001112851342039-04-24U-35612022-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N214028-001112851342039-04-24U-35622022-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N214028-001112851342039-04-24U-32522022-04-2884e616aacf4f…
2026-08-18 06:07:402026-07N214028-001106105182039-04-24U-35622021-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07N214028-001106105182039-04-24U-35612021-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07N214028-001106105182039-04-24U-32522021-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07N214028-001112851342039-04-24U-35612022-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N214028-001112851342039-04-24U-35622022-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N214028-001112851342039-04-24U-32522022-04-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214028-001106105182039-04-24U-35622021-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214028-001106105182039-04-24U-35612021-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214028-001106105182039-04-24U-32522021-11-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214028-001112851342039-04-24U-35612022-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214028-001112851342039-04-24U-35622022-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214028-001112851342039-04-24U-32522022-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214028-001106105182039-04-24U-35622021-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214028-001106105182039-04-24U-35612021-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214028-001106105182039-04-24U-32522021-11-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214028-001112851342039-04-24U-35612022-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214028-001112851342039-04-24U-35622022-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214028-001112851342039-04-24U-32522022-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N214028-001106105182039-04-24U-35622021-11-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214028-001106105182039-04-24U-35612021-11-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214028-001106105182039-04-24U-32522021-11-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214028-001112851342039-04-24U-35612022-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214028-001112851342039-04-24U-35622022-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214028-001112851342039-04-24U-32522022-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214028-001106105182039-04-24U-35622021-11-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214028-001106105182039-04-24U-35612021-11-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214028-001106105182039-04-24U-32522021-11-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214028-001112851342039-04-24U-35612022-04-28fd3edfee7708…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N214028-001D-1872026-03-28c2088c7a36db…
2026-09-14 22:38:342026-08N214028-001D-1872026-03-2884e616aacf4f…
2026-08-18 06:07:402026-07N214028-001D-1872026-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214028-001D-1872026-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214028-001D-1872026-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N214028-001D-1872026-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214028-001D-1872026-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214028-001D-1872026-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214028-001NP2024-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214028-001D-1872026-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214028-001NP2024-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214028-001D-1872026-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214028-001NP2024-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214028-001D-1872026-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214028-001NP2024-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214028-001D-1872026-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214028-001NP2024-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N214028-001D-1872026-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214028-001NP2024-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214028-001D-1872026-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214028-001NP2024-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214028-001D-1872026-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214028-001NP2024-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214028-001D-1872026-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214028-001NP2024-10-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N214028-001D-1872026-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214028-001NP2024-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214028-001NP2024-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214028-001NP2024-10-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214028-001NP2024-10-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214028-001NP2024-10-28782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214028-001NP2024-10-286a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214028-001D-1872026-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214028-001NP2024-10-281c564ffb4f44…
2024-02-18 07:12 UTC2024-02N214028-001D-1872026-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214028-001NP2024-10-28ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N214028-001D-1872026-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214028-001NP2024-10-28a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214028-001D-1872026-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214028-001NP2024-10-289b2671bbb829…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92fc48b4-3815-4611-a8be-f74b29f9b350Product name220260130
c8f45a17-34ae-46eb-871b-470615085910Product name120250630
dad00d81-2cbe-bbab-dd06-a12043b5e56dProduct name420210512
419b812f-d1a6-2de2-5dee-bec68d6ec699Product name220200123
38c480e0-b6d3-b416-6514-a787406e5176Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-7098-01VUITY1 in 1 BOXSOLUTION/ DROPS114
0074-7098-02VUITY2.5 mL in 1 BOTTLESOLUTION/ DROPS2.514
0074-7098-03VUITY3 in 1 BOXSOLUTION/ DROPS314
0074-7098-04VUITY1 in 1 CARTONSOLUTION/ DROPS114
0074-7098-05VUITY1 in 1 CARTONSOLUTION/ DROPS114
0074-7098-05VUITY1.5 mL in 1 BOTTLESOLUTION/ DROPS1.514
0074-7098-06VUITY5 mL in 1 BOTTLESOLUTION/ DROPS514
0074-7098-06VUITY1 in 1 CARTONSOLUTION/ DROPS114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-7098-02ML - Milliliter0074-7098beeb9de3-1b72-4539-91af-d8c61165280712023-02-06
0074-7098-04ML - Milliliter0074-709827a384ed-974a-479b-a116-8cb5e7a70b9e12021-12-08
0074-7098-06ML - Milliliter0074-70983e038256-20c6-4f5d-b5a4-e60acf2343e812023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-7098VUITY (PILOCARPINE HYDROCHLORIDE) SOLUTION/ DROPS [ABBVIE INC.]13Legacy NDC, 8 package rows20230404_8d806897-8a2a-4518-8c68-0ec3b778de50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2584552pilocarpine HCl 1.25 % Ophthalmic SolutionPSN8d806897-8a2a-4518-8c68-0ec3b778de5014
2584557Vuity 1.25 % Ophthalmic SolutionPSN8d806897-8a2a-4518-8c68-0ec3b778de5014
2584557pilocarpine hydrochloride 12.5 MG/ML Ophthalmic Solution [Vuity]SBD8d806897-8a2a-4518-8c68-0ec3b778de5014
2584552pilocarpine hydrochloride 12.5 MG/ML Ophthalmic SolutionSCD8d806897-8a2a-4518-8c68-0ec3b778de5014
2584552pilocarpine hydrochloride 1.25 % Ophthalmic SolutionSY8d806897-8a2a-4518-8c68-0ec3b778de5014
2584557Vuity 12.5 MG/ML Ophthalmic SolutionSY8d806897-8a2a-4518-8c68-0ec3b778de5014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-7098-04000747098041 BOTTLE in 1 CARTON (0074-7098-04) > 5 mL in 1 BOTTLE1 bottle2021-10-280000-00-00NoNoCurrent