FDA.reportPublic FDA data

Latanoprost Ophthalmic Solution

Product NDC
70756-680
11-digit product format
707560680
Labeler code
70756
Product ID
70756-680_0b8d4140-ea72-4ded-bd24-8d81d8963bfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Latanoprost Ophthalmic Solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Lifestar Pharma LLC
Application
ANDA220360
Marketing category
ANDA
Marketing start
2026-03-01
Substance
LATANOPROST
Active strength
50 ug/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
A220360-001LATANOPROSTLATANOPROST0.005%SOLUTION/DROPS / OPHTHALMIC2025-12-17

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 22:38:342026-08A220360-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMIC2025-12-1784e616aacf4f…
2026-08-18 06:07:402026-07A220360-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMIC2025-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220360-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMICAT2025-12-17011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220360-001LATANOPROST0.005%SOLUTION/DROPS / OPHTHALMIC2025-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A220360-001AT1011fe1cb6892…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Latanoprost Ophthalmic Solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LATANOPROST50 ug/mL

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
de829a7d-0b51-4e4d-a051-6a6568f15688Product name120230919
203382e3-d801-4f70-866f-ebe316583560Product name120190624
e516be5e-351f-4b2e-a26b-fdff13181605Product name120181220
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-680-00Latanoprost Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS13
70756-680-15Latanoprost Ophthalmic Solution2.5 mL in 1 BOTTLESOLUTION/ DROPS2.53

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSN2c87e99e-33d4-4060-8876-ff05557c05eb3
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD2c87e99e-33d4-4060-8876-ff05557c05eb3
314072latanoprost 0.005 % Ophthalmic SolutionSY2c87e99e-33d4-4060-8876-ff05557c05eb3
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY2c87e99e-33d4-4060-8876-ff05557c05eb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-680-00707560680001 in 1 CARTONHistorical
70756-680-15707560680151 BOTTLE in 1 CARTON (70756-680-15) / 2.5 mL in 1 BOTTLE1 bottle2026-03-01NoNoCurrent