Indications and uses
LASTACAFT ® is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.
LASTACAFT
- Manufacturer
- Rebel Distributors Corp | PSS World Medical, Inc. | STAT RX USA LLC | Dispensing Solutions, Inc. | SCRIPT PAK | Keltman Pharmaceuticals, Inc. | Rebel Distirbutors Corp.
- Effective date
- 2012-09-05
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:16:34
Label at a glance#
ProductLASTACAFT
Active ingredientalcaftadine
Label structure14 sections
Dosage and administration
Instill one drop in each eye once daily.
Storage and handling
LASTACAFT ® (alcaftadine ophthalmic solution) 0.25% is supplied in an opaque, white low-density polyethylene bottle with a white polypropylene cap. 3 mL fill in 5 mL bottle NDC 42254-288-03 Storage: Store at 15-25°C (59-77°F).
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
1 INDICATIONS AND USAGE
LASTACAFT® is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.
2 DOSAGE AND ADMINISTRATION
Instill one drop in each eye once daily.
3 DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution containing alcaftadine, 0.25% (2.5 mg/mL).
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Contamination of Tip and Solution
To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.
5.2 Contact Lens Use
Patients should be advised not to wear a contact lens if their eye is red. LASTACAFT® should not be used to treat contact lens-related irritation.
LASTACAFT® should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of LASTACAFT® . The preservative in LASTACAFT® , benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of LASTACAFT® .
5.3 Topical Ophthalmic Use Only
LASTACAFT® is for topical ophthalmic use only.
6 ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
6.1 Ocular Adverse Reactions
The most frequent ocular adverse reactions, occurring in < 4% of LASTACAFT® treated eyes, were eye irritation, burning and/or stinging upon instillation, eye redness and eye pruritus.
6.2 Non-ocular Adverse Reactions
The most frequent non-ocular adverse reactions, occurring in < 3% of subjects with LASTACAFT® treated eyes, were nasopharyngitis, headache and influenza. Some of these events were similar to the underlying disease being studied.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category B. Reproduction studies performed in rats and rabbits revealed no evidence of impaired female reproduction or harm to the fetus due to alcaftadine. Oral doses in rats and rabbits of 20 and 80 mg/kg/day, respectively, produced plasma exposure levels approximately 200 and 9000 times the plasma exposure at the recommended human ocular dose. There are however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
8.3 Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LASTACAFT® is administered to a nursing woman.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
8.5 Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger subjects.
11 DESCRIPTION
LASTACAFT® is a sterile, topically administered H1 receptor antagonist containing alcaftadine for ophthalmic use.
Alcaftadine is a white to yellow powder with an empirical formula of C19H21N3O and a molecular weight of 307.39.
Contains: Active: alcaftadine 0.25% (2.5 mg/mL). Preservative: benzalkonium chloride 0.005%. Inactives: edetate disodium; sodium phosphate, monobasic; purified water; sodium chloride; sodium hydroxide and/or hydrochloric acid to adjust pH
Chemical Name: 6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-imidazo[2,1-b] [3] benzazepine-3-carboxaldehyde
Structural Formula:
The drug product has a pH of approximately 7 and an osmolality of approximately 290 mOsm/kg.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Alcaftadine is an H1 histamine receptor antagonist and inhibitor of the release of histamine from mast cells. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.
12.3 Pharmacokinetics
SPL UNCLASSIFIED SECTION
Absorption
Following bilateral topical ocular administration of alcaftadine ophthalmic solution, 0.25%, the mean plasma Cmax of alcaftadine was approximately 60 pg/mL and the median Tmax occurred at 15 minutes. Plasma concentrations of alcaftadine were below the lower limit of quantification (10 pg/mL) by 3 hours after dosing. The mean Cmax of the active carboxylic acid metabolite was approximately 3 ng/mL and occurred at 1 hour after dosing. Plasma concentrations of the carboxylic acid metabolite were below the lower limit of quantification (100 pg/mL) by 12 hours after dosing. There was no indication of systemic accumulation or changes in plasma exposure of alcaftadine or the active metabolite following daily topical ocular administration.
SPL UNCLASSIFIED SECTION
Distribution
The protein binding of alcaftadine and the active metabolite are 39.2% and 62.7%, respectively.
SPL UNCLASSIFIED SECTION
Metabolism
The metabolism of alcaftadine is mediated by non-CYP450 cytosolic enzymes to the active carboxylic acid metabolite.
SPL UNCLASSIFIED SECTION
Excretion
The elimination half-life of the carboxylic acid metabolite is approximately 2 hours following topical ocular administration. Based on data following oral administration of alcaftadine, the carboxylic acid metabolite is primarily eliminated unchanged in the urine.
In vitro studies showed that neither alcaftadine nor the carboxylic acid metabolite substantially inhibited reactions catalyzed by major CYP450 enzymes.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Alcaftadine was not mutagenic or genotoxic in the Ames test, the mouse lymphoma assay or the mouse micronucleus assay.
Alcaftadine was found to have no effect on fertility of male and female rats at oral doses up to 20 mg/kg/day (approximately 200 times the plasma exposure at the recommended human ocular dose).
14 CLINICAL STUDIES
Clinical efficacy was evaluated in conjunctival allergen challenge (CAC) studies. LASTACAFT® was more effective than its vehicle in preventing ocular itching in patients with allergic conjunctivitis induced by an ocular allergen challenge, both at 3 minutes post-dosing and at 16 hours post-dosing of LASTACAFT® .
The safety of LASTACAFT® was evaluated in a randomized clinical study of 909 subjects over a period of 6 weeks.
16 HOW SUPPLIED/STORAGE AND HANDLING
LASTACAFT® (alcaftadine ophthalmic solution) 0.25% is supplied in an opaque, white low-density polyethylene bottle with a white polypropylene cap.
3 mL fill in 5 mL bottle NDC 42254-288-03
STORAGE AND HANDLING SECTION
Storage: Store at 15-25°C (59-77°F).
17 PATIENT COUNSELING INFORMATION
17.1 Sterility of Dropper Tip
Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.
17.2 Concomitant Use of Contact Lenses
Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that LASTACAFT® should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of LASTACAFT® . The preservative in LASTACAFT® , benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of LASTACAFT® .
17.3 Topical Ophthalmic Use Only
For topical ophthalmic administration only.
ALLERGAN
Manufactured for Allergan, Inc., Irvine, CA 92612, U.S.A.
© 2011 Allergan, Inc.
® marks owned by Allergan, Inc.
Made in the U.S.A.
72409US11C
Repackaged by:
REBEL DISTRIBUTORS CORP.
Thousand Oaks, CA 91320
Principal display panel
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1000085 | alcaftadine 0.25 % Ophthalmic Solution | PSN | 1 |
| 1000089 | LASTACAFT 0.25 % Ophthalmic Solution | PSN | 1 |
| 1000089 | alcaftadine 2.5 MG/ML Ophthalmic Solution [Lastacaft] | SBD | 1 |
| 1000085 | alcaftadine 2.5 MG/ML Ophthalmic Solution | SCD | 1 |
| 1000085 | alcaftadine 0.25 % Ophthalmic Solution | SY | 1 |
| 1000089 | Lastacaft 0.25 % Ophthalmic Solution | SY | 1 |
| 1000089 | Lastacaft 2.5 MG/ML Ophthalmic Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ALCAFTADINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4b7a6bd5-956e-f134-86e5-d4d9706c15d4 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42254-288-03 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c9b-c013-e053-90daa90a1393 | These highlights do not include all the information needed to use LASTACAFT ® safely and effectively. See full prescribing information for LASTACAFT ® . LASTACAFT ® (alcaftadine ophthalmic solution) 0.25% Initial U.S. Approval: 2010 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-288-03 | LASTACAFT | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 1 | |
| 42254-288-03 | LASTACAFT | 3 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 3 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-288-03 | ML - Milliliter | 42254-288 | c48bafa0-8678-4a9d-b413-57319d6431bc | 1 | 2013-03-03 |
| 0023-4290-03 | ML - Milliliter | 0023-4290 | 768cda39-1ce2-4415-83ce-8876eb65cc23 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| alcaftadine | ACTIVE INGREDIENT | 7Z8O94ECSX | 1 | |
| alcaftadine | ACTIVE MOIETY | 7Z8O94ECSX | 1 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | 1 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| sodium phosphate, monobasic | INACTIVE INGREDIENT | 3980JIH2SW | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- LASTACAFT
- alcaftadine
- benzalkonium chloride
- edetate disodium
- sodium phosphate, monobasic
- water
- sodium chloride
- sodium hydroxide
- hydrochloric acid
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42254-288 | 42254-288-03 |
| 0023-4290 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| alcaftadine | 7Z8O94ECSX | ACTIB |
| benzalkonium chloride | F5UM2KM3W7 | IACT |
| edetate disodium | 7FLD91C86K | IACT |
| sodium phosphate, monobasic | 3980JIH2SW | IACT |
| water | 059QF0KO0R | IACT |
| sodium chloride | 451W47IQ8X | IACT |
| sodium hydroxide | 55X04QC32I | IACT |
| hydrochloric acid | QTT17582CB | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 0.22 mg | ||
| sodium chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | INJECTION / INTRAMUSCULAR | 161 mg | ||
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 13.2 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | INJECTION / INTRAVENOUS | 161 mg | ||
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.07 %w/v | ||
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | SYSTEM / IONTOPHORESIS | 14.2 mg | ||
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | SOLUTION / ORAL | 25 mg/5ml | ||
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | TABLET / ORAL | 2 mg | ||
| sodium phosphate, monobasic | SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | SYSTEM / TOPICAL | 14.2 mg | ||
| benzalkonium chloride | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %w/v | ||
| hydrochloric acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022134-001 | LASTACAFT | ALCAFTADINE | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 |
| N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 |
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 | 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 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022134-001 | LASTACAFT | 0.25% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 2010-07-28 | 3a93d1ddd44b… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022134-001 | 10617695 | 2027-03-19 | U-3267 | Drug product | 2020-05-12 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022134-001 | 8664215 | 2027-12-23 | U-3267 | 2014-03-21 | 4b0b4de00fa7… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LASTACAFT | ALCAFTADINE | Allergan, Inc. | 17d37e8d-7825-424b-b6ca-0a85d0bf4694 | 2020-06-01 | Warnings, Adverse reactions | 0023-4290 |
| 4b8c6afe-2d76-46c7-a23e-99db5e180ff6 | 4b8c6afe-2d76-46c7-a23e-99db5e180ff6 | 2012-09-05 | Warnings, Adverse reactions | 4b8c6afe-2d76-46c7-a23e-99db5e180ff6 4b8c6afe-2d76-46c7-a23e-99db5e180ff6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.