latanoprost

Product NDC: 68083-609
Requested package NDC: 68083-609-01
11-digit product format: 680830609
Labeler code: 68083
Product ID: 68083-609_c63757a2-c757-4098-a29d-7a94104d050f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: latanoprost
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Gland Pharma Limited
Application: ANDA218257
Marketing category: ANDA
Marketing start: 2024-11-26
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218257-001	LATANOPROST	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT		2024-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218257-001	AT

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218257-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218257-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218257-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218257-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218257-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218257-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218257-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218257-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218257-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-11-26	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218257-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2024-11-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218257-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218257-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218257-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218257-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218257-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218257-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218257-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218257-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218257-001	AT	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218257-001	AT	1	`a50c72e98297…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LATANOPROST	50 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6Z5B6HVF6O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
113abcc6-6e5c-4a57-ad6a-d69508ee990e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8d59b88b-5059-46d6-8e48-d5d9371caa10	Product name	2	20260211
f6b0b05b-3bf2-088a-8ccc-e1cf01a91e86	Product name	4	20250729
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
de829a7d-0b51-4e4d-a051-6a6568f15688	Product name	1	20230919
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
203382e3-d801-4f70-866f-ebe316583560	Product name	1	20190624
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
e516be5e-351f-4b2e-a26b-fdff13181605	Product name	1	20181220
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-609-01	latanoprost	1 in 1 CARTON	SOLUTION/ DROPS	1		5
68083-609-01	latanoprost	2.5 mL in 1 BOTTLE	SOLUTION/ DROPS	2.5		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-609	LATANOPROST SOLUTION/ DROPS [GLAND PHARMA LIMITED]	5	Current NDC, 2 package rows	20241205_113abcc6-6e5c-4a57-ad6a-d69508ee990e.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
latanoprost	LATANOPROST	GLENMARK PHARMACEUTICALS INC	821d2ad5-a430-4fd2-8cfd-50b2118b8639	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218257 application number: ANDA218257
Latanoprost	LATANOPROST	Sagent Pharmaceuticals	7474dc53-e5e5-44f2-9f56-b2cbacdc0c32	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218257 application number: ANDA218257
latanoprost	LATANOPROST	Gland Pharma Limited	113abcc6-6e5c-4a57-ad6a-d69508ee990e	2024-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218257 application number: ANDA218257 ndc (package): 68083-609-01 ndc (product): 68083-609 ndc11 (package): 68083060901

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6Z5B6HVF6O	LATANOPROST	130209-82-4	LATANOPROST

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314072	latanoprost 0.005 % Ophthalmic Solution	PSN	113abcc6-6e5c-4a57-ad6a-d69508ee990e	5
314072	latanoprost 0.05 MG/ML Ophthalmic Solution	SCD	113abcc6-6e5c-4a57-ad6a-d69508ee990e	5
314072	latanoprost 0.005 % Ophthalmic Solution	SY	113abcc6-6e5c-4a57-ad6a-d69508ee990e	5
314072	latanoprost 125 MCG per 2.5 ML Ophthalmic Solution	SY	113abcc6-6e5c-4a57-ad6a-d69508ee990e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68083-609-01	68083060901	1 BOTTLE in 1 CARTON (68083-609-01) / 2.5 mL in 1 BOTTLE	1 bottle	2024-11-26	No	No	Current