topcare lansoprazole

Product NDC: 36800-392
Requested package NDC: 36800-392-03
11-digit product format: 368000392
Labeler code: 36800
Product ID: 36800-392_f5217e63-e0c1-4899-8bf0-e480d65e282f
Type: HUMAN OTC DRUG
Nonproprietary name: Lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA202319
Marketing category: ANDA
Marketing start: 2021-07-29
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
A202319-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL			2012-05-18

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	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`cb3db0bc1861…`

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
596843	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
73aec019-5337-48a4-b95c-993fff9cfc2a	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	SPL version
36800-392-01	topcare lansoprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	4
36800-392-01	topcare lansoprazole	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	4
36800-392-03	topcare lansoprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	4
36800-392-03	topcare lansoprazole	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-392	TOPCARE LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TOPCO ASSOCIATES LLC]	4	Current NDC, Legacy NDC, 4 package rows	20250221_73aec019-5337-48a4-b95c-993fff9cfc2a.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
careone acid reducer	LANSOPRAZOLE	Retail Business Services, LLC	e6b42dec-3545-483f-97db-9375b3732fba	2026-07-08	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
BERKLEY AND JENSEN LANSOPRAZOLE	LANSOPRAZOLE	BJWC	b859e8dc-e42e-448d-89fa-2fc79d9cac32	2026-05-21	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
good neighbor pharmacy lansoprazole	LANSOPRAZOLE	Amerisource Bergen	a4ee8db4-8f8e-4326-bd32-43abd53be8e4	2025-12-01	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
Prevacid 24 HR	LANSOPRAZOLE	L. Perrigo Company	205c9c1e-b422-4e86-a4b0-714b608adc19	2025-06-24	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
lansoprazole	LANSOPRAZOLE	Meijer Distribution Inc	b202a695-4265-4b3b-bab8-593d47962382	2025-06-12	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
lansoprazole	LANSOPRAZOLE	Walgreen Company	afcd7c51-9333-4d6f-ad18-ed95baecc7ce	2025-05-12	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
up and up lansoprazole	LANSOPRAZOLE	Target Corporation	16ceaead-8dc0-49de-9438-caa146e13fba	2025-04-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	bd278054-875e-4877-991c-cbdf3975f93e	2025-03-31	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
lansoprazole	LANSOPRAZOLE	Padagis Israel Pharmaceuticals Ltd	17f41872-f3d1-4b02-b6ce-0e731139495a	2025-03-26	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
equate lansoprazole	LANSOPRAZOLE	WALMART INC.	3a7aadbd-0a70-444f-95e1-cbde82781892	2025-03-14	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
dg health lansoprazole	LANSOPRAZOLE	Dolgencorp Inc	e6e3bcee-636f-4361-85f8-9ba5a0f3c741	2025-03-04	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
equaline lansoprazole	LANSOPRAZOLE	United Natural Foods, Inc. dba UNFI	bf8c337c-4a45-46e6-ae8e-46df80ca66e3	2025-02-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
lansoprazole	LANSOPRAZOLE	Publix Super Markets Inc	86a99ee3-0e98-46e8-8473-f8c812044a2f	2025-02-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
topcare lansoprazole	LANSOPRAZOLE	Topco Associates LLC	73aec019-5337-48a4-b95c-993fff9cfc2a	2025-02-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319 ndc (package): 36800-392-03 ndc (product): 36800-392 ndc11 (package): 36800039203
Kirkland Signature Lansoprazole	LANSOPRAZOLE	Costco Wholesale Company	326aabe6-c4ac-4bca-949f-38015dcbaf4e	2025-02-12	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
basic care lansoprazole	LANSOPRAZOLE	Amazon.com Services LLC	6b57eb00-74fd-435f-bd08-086c9f8ac62c	2025-02-05	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
Members Mark Lansoprazole	LANSOPRAZOLE	Sam's West Inc	fee84ce3-a884-4944-a32b-72e69a1229d4	2024-07-15	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
Good Sense Lansoprazole	LANSOPRAZOLE	L. Perrigo Company	91d69826-df5c-47a2-b852-3083629d1893	2024-06-17	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
foster and thrive acid reducer	LANSOPRAZOLE	Strategic Sourcing Services LLC	d02e2f93-3358-4682-b491-0a83889af8a1	2023-09-14	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319
basic care lansoprazole	LANSOPRAZOLE	Amazon.com Services LLC	5ab07bf7-140a-4ca0-9b3a-38da7aa454db	2022-12-13	Warnings	Exact identifier application applno (ANDA): 202319 application number: ANDA202319

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
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	73aec019-5337-48a4-b95c-993fff9cfc2a	4
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	73aec019-5337-48a4-b95c-993fff9cfc2a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-392-03	36800039203	3 BOTTLE in 1 CARTON (36800-392-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2021-07-29	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	2025-02-13	HUMAN OTC DRUG LABEL	4