topcare Lansoprazole

Product NDC: 36800-295
11-digit product format: 368000295
Labeler code: 36800
Product ID: 36800-295_d6083bce-520b-4c14-bd0f-698e33b4b4f6
Type: HUMAN OTC DRUG
Nonproprietary name: lansoprazole
Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route: ORAL
Labeler: Topco Associates LLC
Application: NDA208025
Marketing category: NDA
Marketing start: 2020-06-18
Substance: LANSOPRAZOLE
Active strength: 15 mg/1
Pharmacologic classes: Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
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 1.

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
N208025-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL			2016-06-07

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208025-001	11077055	2036-04-21		Drug product	2021-08-03
N208025-001	11986554	2036-04-21		Drug product	2024-05-21

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208025-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	2016-06-07	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208025-001	11986554	2036-04-21	Drug product	2024-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208025-001	11077055	2036-04-21	Drug product	2021-08-03	`053a50430f4f…`

Additional Listing Data#

Finished product: Yes
Brand name base: topcare Lansoprazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LANSOPRAZOLE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0K5C5T2QPG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351261	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
ec5d6d5c-11e7-4932-a48f-fb72218ceccd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d6b97638-59f4-48e2-8959-569628732c46	Product name	9	20210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-295-74	topcare Lansoprazole	14 in 1 CARTON	TABLET, ORALLY DISINTEGRATING, D	14		4
36800-295-74	topcare Lansoprazole	1 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING, D	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-295	TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [TOPCO ASSOCIATES LLC]	4	Current NDC, Legacy NDC, 2 package rows	20250228_ec5d6d5c-11e7-4932-a48f-fb72218ceccd.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Walgreen Company	a72f92cc-db49-40ef-a249-6b7c50dc8ef2	2026-02-28	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
lansoprazole	LANSOPRAZOLE	Kroger Company	4c0684b5-5c18-4ed5-8185-8b5d51dce3a0	2025-02-08	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
Lansoprazole	LANSOPRAZOLE	CVS Pharmacy	992a8f95-475c-4e57-90cc-9839c8678427	2025-02-08	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
topcare Lansoprazole	LANSOPRAZOLE	Topco Associates LLC	ec5d6d5c-11e7-4932-a48f-fb72218ceccd	2025-02-08	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025 ndc (product): 36800-295
Good Sense Lansoprazole	LANSOPRAZOLE	L. Perrigo Company	d86585b7-e146-4f04-9016-412b16e06f55	2025-01-29	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
basic care lansoprazole	LANSOPRAZOLE	Amazon.com Services LLC	f39feec2-54fb-47d4-9b45-08f75e92117e	2025-01-24	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025
equate lansoprazole	LANSOPRAZOLE	Wal-Mart Stores Inc	89b91d5f-008c-4e9d-83e0-23b673b9c469	2022-12-07	Warnings	Exact identifier application applno (NDA): 208025 application number: NDA208025

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K5C5T2QPG	LANSOPRAZOLE	103577-45-3	LANSOPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351261	lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet	PSN	ec5d6d5c-11e7-4932-a48f-fb72218ceccd	4
351261	lansoprazole 15 MG Disintegrating Oral Tablet	SCD	ec5d6d5c-11e7-4932-a48f-fb72218ceccd	4
351261	lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet	SY	ec5d6d5c-11e7-4932-a48f-fb72218ceccd	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-295-74	36800029574	14 BLISTER PACK in 1 CARTON (36800-295-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK	14 blister pack	2020-06-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Lansoprazole Drug Facts	Topco Associates LLC	2025-02-08	HUMAN OTC DRUG LABEL	4