Latanoprost

Product NDC
61314-547
11-digit product format
613140547
Labeler code
61314
Product ID
61314-547_a4388e84-6b82-4d7d-915b-6997d4b44b36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Latanoprost
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA091449
Marketing category
ANDA
Marketing start
2011-01-07
Substance
LATANOPROST
Active strength
50 ug/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 42.

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
A091449-001LATANOPROSTLATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A091449-001AT

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-223f01610625f2…
2019-09-15 20:21 UTC2019-09A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091449-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2011-03-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091449-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091449-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091449-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091449-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091449-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091449-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091449-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091449-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091449-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091449-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091449-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091449-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091449-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091449-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091449-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091449-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091449-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091449-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091449-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091449-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091449-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091449-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A091449-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091449-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091449-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091449-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A091449-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091449-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091449-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091449-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091449-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091449-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091449-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091449-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091449-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091449-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091449-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091449-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091449-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091449-001AT1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LATANOPROST50 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6Z5B6HVF6OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
314072Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1fba56a6-c8dc-4f34-b05d-efdea75d2feaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8d59b88b-5059-46d6-8e48-d5d9371caa10Product name220260211
f6b0b05b-3bf2-088a-8ccc-e1cf01a91e86Product name420250729
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
de829a7d-0b51-4e4d-a051-6a6568f15688Product name120230919
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
203382e3-d801-4f70-866f-ebe316583560Product name120190624
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e516be5e-351f-4b2e-a26b-fdff13181605Product name120181220
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-547-01Latanoprost2.5 mL in 1 BOTTLESOLUTION2.59
61314-547-01Latanoprost1 in 1 CARTONSOLUTION19
61314-547-03Latanoprost2.5 mL in 1 BOTTLESOLUTION2.59
61314-547-03Latanoprost3 in 1 CARTONSOLUTION39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-547-01ML - Milliliter61314-5476f071d6a-d9ee-4473-aeea-59a40ecb838312012-07-24
61314-547-03ML - Milliliter61314-547b9466009-83b3-4ad1-8444-033807fc92bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LATANOPROSTACTIVE INGREDIENT6Z5B6HVF6OLATANOPROST SOLUTION [SANDOZ INC]2
LATANOPROSTACTIVE MOIETY6Z5B6HVF6OLATANOPROST SOLUTION [SANDOZ INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLATANOPROST SOLUTION [SANDOZ INC]2
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FLATANOPROST SOLUTION [SANDOZ INC]2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNLATANOPROST SOLUTION [SANDOZ INC]2
WATERINACTIVE INGREDIENT059QF0KO0RLATANOPROST SOLUTION [SANDOZ INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-547LATANOPROST SOLUTION [SANDOZ INC]9Current NDC, Legacy NDC, 4 package rows20241207_1fba56a6-c8dc-4f34-b05d-efdea75d2fea.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LatanoprostLATANOPROSTNuCare Pharmaceuticals, Inc.3c47a089-2c72-f58c-e063-6294a90a4cce2025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091449
application number: ANDA091449
LatanoprostLATANOPROSTA-S Medication Solutions8fb5edec-d94a-4aad-b42e-756267a3ae552024-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091449
application number: ANDA091449
LatanoprostLATANOPROSTSandoz Inc1fba56a6-c8dc-4f34-b05d-efdea75d2fea2023-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091449
application number: ANDA091449
ndc (product): 61314-547

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSN1fba56a6-c8dc-4f34-b05d-efdea75d2fea9
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD1fba56a6-c8dc-4f34-b05d-efdea75d2fea9
314072latanoprost 0.005 % Ophthalmic SolutionSY1fba56a6-c8dc-4f34-b05d-efdea75d2fea9
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY1fba56a6-c8dc-4f34-b05d-efdea75d2fea9
314072latanoprost 0.005 % Ophthalmic SolutionPSN8fb5edec-d94a-4aad-b42e-756267a3ae552
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD8fb5edec-d94a-4aad-b42e-756267a3ae552
314072latanoprost 0.005 % Ophthalmic SolutionSY8fb5edec-d94a-4aad-b42e-756267a3ae552
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY8fb5edec-d94a-4aad-b42e-756267a3ae552
314072latanoprost 0.005 % Ophthalmic SolutionPSN3c47a089-2c72-f58c-e063-6294a90a4cce1
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD3c47a089-2c72-f58c-e063-6294a90a4cce1
314072latanoprost 0.005 % Ophthalmic SolutionSY3c47a089-2c72-f58c-e063-6294a90a4cce1
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY3c47a089-2c72-f58c-e063-6294a90a4cce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-547-01613140547011 BOTTLE in 1 CARTON (61314-547-01) / 2.5 mL in 1 BOTTLE1 bottle2011-01-070000-00-00NoNoCurrent
61314-547-03613140547033 BOTTLE in 1 CARTON (61314-547-03) / 2.5 mL in 1 BOTTLE3 bottle2011-01-070000-00-00NoNoCurrent