Lansoprazole

Product NDC: 57896-761
11-digit product format: 578960761
Labeler code: 57896
Product ID: 57896-761_d4c48506-6a3d-4d6b-2c7c-4315b16f73a0
Type: HUMAN OTC DRUG
Nonproprietary name: Lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Gericare Pharmaceuticals
Application: ANDA202194
Marketing category: ANDA
Marketing start: 2013-04-25
Marketing end: 0000-00-00
Substance: LANSOPRAZOLE
Active strength: 15 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	57896-761		D	Discontinued by firm		2026-08-07
excluded package	package	57896-761	57896-761-42	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 17 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57896-761-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57896-761-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57896-761-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57896-761-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57896-761-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57896-761-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57896-761-42	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57896-761-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57896-761-42	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57896-761-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57896-761-42	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57896-761-42	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A202194-001	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	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
Lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57896-761	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [GERICARE PHARMACEUTICALS]	4	Legacy NDC	20241203_62dce6af-b33d-fa49-7861-670565fdf6e1.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Dr. Reddy's Laboratories Inc.	4a701c0d-fef5-aa12-01e6-e3680a161a7d	2026-07-21	Warnings	Exact identifier application applno (ANDA): 202194 application number: ANDA202194
Lansoprazole	LANSOPRAZOLE	Rugby Laboratories, Inc	aa95216c-8985-d160-1743-ba168a35177f	2026-07-17	Warnings	Exact identifier application applno (ANDA): 202194 application number: ANDA202194
Lansoprazole	LANSOPRAZOLE	Dr. Reddy's Laboratories Inc.	a24acc0b-7770-1087-77bd-048259a5bf72	2026-07-15	Warnings	Exact identifier application applno (ANDA): 202194 application number: ANDA202194
Lansoprazole	LANSOPRAZOLE	LEADER/ Cardinal Health 110, Inc.	486838cd-17ee-c2df-4e05-aa6106dd8fd8	2026-07-15	Warnings	Exact identifier application applno (ANDA): 202194 application number: ANDA202194
Lansoprazole	LANSOPRAZOLE	Dr. Reddy's Laboratories Limited	15e05eda-48aa-a4b7-4b8a-4ee1cf110120	2026-07-09	Warnings	Exact identifier application applno (ANDA): 202194 application number: ANDA202194
Lansoprazole	LANSOPRAZOLE	AMERISOURCEBERGEN DRUG CORPORATION	accb92e8-dd14-b87b-c20a-6c4803815bc2	2026-04-17	Warnings	Exact identifier application applno (ANDA): 202194 application number: ANDA202194
Lansoprazole	LANSOPRAZOLE	Chain Drug Marketing Association	74417c65-cccd-5a6a-0f96-0d8cb5a1592a	2025-07-18	Warnings	Exact identifier application applno (ANDA): 202194 application number: ANDA202194
Lansoprazole	LANSOPRAZOLE	Walgreens company	277093d5-cd0f-36ad-63d4-824a62d2a16c	2025-07-18	Warnings	Exact identifier application applno (ANDA): 202194 application number: ANDA202194

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57896-761-42	57896076142	3 BOTTLE in 1 PACKAGE, COMBINATION (57896-761-42) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	3 bottle	2013-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole Delayed Release Capsules USP	Gericare Pharmaceuticals	2024-12-01	HUMAN OTC DRUG LABEL	4