FDA.reportPublic FDA data

TRYPTYR

Product NDC
0065-8595
11-digit product format
000658595
Labeler code
0065
Product ID
0065-8595_27fdd84a-2d62-4c79-afb0-5d5bd608fdfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acoltremon
Dosage form
SOLUTION
Route
OPHTHALMIC; TOPICAL
Labeler
Alcon Laboratories, Inc.
Application
NDA217370
Marketing category
NDA
Marketing start
2025-07-23
Substance
ACOLTREMON
Active strength
.03 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N217370-001TRYPTYRACOLTREMON0.003%SOLUTION/DROPS / OPHTHALMICRLD, RS2025-05-28

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217370-001100289202031-09-08U-19002025-06-20
N217370-00190956092031-09-08U-1900Drug product2025-06-20
N217370-00194336792031-09-08U-19002025-06-20
N217370-001118502212042-12-16U-1900Drug product2025-06-20
N217370-001123369712042-12-16U-19002025-07-23

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N217370-001NCE2030-05-28

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
2026-09-14 22:38:342026-08N217370-001TRYPTYR0.003%SOLUTION/DROPS / OPHTHALMICRLD, RS2025-05-2884e616aacf4f…
2026-08-18 06:07:402026-07N217370-001TRYPTYR0.003%SOLUTION/DROPS / OPHTHALMICRLD, RS2025-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217370-001TRYPTYR0.003%SOLUTION/DROPS / OPHTHALMICRLD, RS2025-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217370-001TRYPTYR0.003%SOLUTION/DROPS / OPHTHALMICRLD, RS2025-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N217370-001TRYPTYR0.003%SOLUTION/DROPS / OPHTHALMICRLD, RS2025-05-286a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217370-001TRYPTYR0.003%SOLUTION/DROPS / OPHTHALMICRLD, RS2025-05-28a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217370-001100289202031-09-08U-19002025-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N217370-00190956092031-09-08U-1900Drug product2025-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N217370-00194336792031-09-08U-19002025-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N217370-001118502212042-12-16U-1900Drug product2025-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N217370-001123369712042-12-16U-19002025-07-2384e616aacf4f…
2026-08-18 06:07:402026-07N217370-001100289202031-09-08U-19002025-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217370-00190956092031-09-08U-1900Drug product2025-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217370-00194336792031-09-08U-19002025-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217370-001118502212042-12-16U-1900Drug product2025-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N217370-001123369712042-12-16U-19002025-07-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217370-001100289202031-09-08U-19002025-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217370-00190956092031-09-08U-1900Drug product2025-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217370-00194336792031-09-08U-19002025-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217370-001118502212042-12-16U-1900Drug product2025-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217370-001123369712042-12-16U-19002025-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217370-001100289202031-09-08U-19002025-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217370-00190956092031-09-08U-1900Drug product2025-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217370-00194336792031-09-08U-19002025-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217370-001118502212042-12-16U-1900Drug product2025-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217370-001123369712042-12-16U-19002025-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N217370-001100289202031-09-08U-19002025-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217370-00190956092031-09-08U-1900Drug product2025-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217370-00194336792031-09-08U-19002025-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217370-001118502212042-12-16U-1900Drug product2025-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217370-001123369712042-12-16U-19002025-07-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217370-001100289202031-09-08U-19002025-06-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217370-00190956092031-09-08U-1900Drug product2025-06-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217370-00194336792031-09-08U-19002025-06-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217370-001118502212042-12-16U-1900Drug product2025-06-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217370-001123369712042-12-16U-19002025-07-23a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N217370-001NCE2030-05-2884e616aacf4f…
2026-08-18 06:07:402026-07N217370-001NCE2030-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217370-001NCE2030-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217370-001NCE2030-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N217370-001NCE2030-05-286a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217370-001NCE2030-05-28a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
TRYPTYR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACOLTREMON.03 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1L7BVT4Z4ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2716821Internal RxNorm lookup
2716826Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b7715a1-035c-4002-b582-5238efee5d58Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f6730f9-3fbd-463c-9435-b601f001321fProduct name120260310

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-8595-01TRYPTYR5 in 1 POUCHSOLUTION56
0065-8595-01TRYPTYR3 in 1 CARTONSOLUTION36
0065-8595-02TRYPTYR12 in 1 CARTONSOLUTION126
0065-8595-02TRYPTYR5 in 1 POUCHSOLUTION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-8595-02EA - Each0065-85959095cad4-ba48-468e-a348-b15a8628c86e12025-07-08

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRYPTYRACOLTREMONAlcon Laboratories, Inc.2b7715a1-035c-4002-b582-5238efee5d582025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 217370
application number: NDA217370
ndc (product): 0065-8595

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2716821acoltremon 0.003 % Ophthalmic SolutionPSN2b7715a1-035c-4002-b582-5238efee5d586
2716826TRYPTYR 0.003 % Ophthalmic SolutionPSN2b7715a1-035c-4002-b582-5238efee5d586
2716826acoltremon 0.03 MG/ML Ophthalmic Solution [Tryptyr]SBD2b7715a1-035c-4002-b582-5238efee5d586
2716821acoltremon 0.03 MG/ML Ophthalmic SolutionSCD2b7715a1-035c-4002-b582-5238efee5d586
2716821acoltremon 0.003 % Ophthalmic SolutionSY2b7715a1-035c-4002-b582-5238efee5d586
2716826Tryptyr 0.003 % Ophthalmic SolutionSY2b7715a1-035c-4002-b582-5238efee5d586
2716826Tryptyr 0.03 MG/ML Ophthalmic SolutionSY2b7715a1-035c-4002-b582-5238efee5d586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0065-8595-01000658595013 POUCH in 1 CARTON (0065-8595-01) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL3 pouch2025-07-23YesNoCurrent
0065-8595-020006585950212 POUCH in 1 CARTON (0065-8595-02) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL12 pouch2025-07-23NoNoCurrent