Prevacid

Product NDC: 64764-541
11-digit product format: 647640541
Labeler code: 64764
Product ID: 64764-541_ac2f4316-0a09-466f-bf6d-4772fb633ecb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA020406
Marketing category: NDA
Marketing start: 1995-05-10
Marketing end: 0000-00-00
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: 2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64764-541		D	Discontinued by firm	2026-08-17
excluded package	package	64764-541	64764-541-05	D	Discontinued by firm	2026-08-17
excluded package	package	64764-541	64764-541-11	D	Discontinued by firm	2026-08-17
excluded package	package	64764-541	64764-541-19	D	Discontinued by firm	2026-08-17
excluded package	package	64764-541	64764-541-30	D	Discontinued by firm	2026-08-17

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 · 60 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	64764-541-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-541-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-541-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-541-30	`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	64764-541-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-541-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-541-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-541-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-541-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-541-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-541-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-541-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-541-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-541-19	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-541-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-541-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-541-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-541-19	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-541-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-541-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-541-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-541-19	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-541-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-541-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-541-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-541-19	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-541-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-541-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-541-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-541-19	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-541-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-541-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-541-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-541-19	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-541-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-541-30	`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	64764-541-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-541-19	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-541-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-541-30	`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	64764-541-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64764-541-19	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64764-541-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64764-541-30	`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	64764-541-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64764-541-19	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64764-541-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64764-541-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020406-001	PREVACID	LANSOPRAZOLE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10
N020406-002	PREVACID	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020406-002	AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020406-001	PREVACID	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020406-001	PREVACID	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020406-001	PREVACID	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020406-001	PREVACID	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	1995-05-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020406-001	PREVACID	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020406-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020406-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020406-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020406-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020406-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020406-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020406-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020406-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020406-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020406-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020406-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020406-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020406-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020406-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020406-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020406-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020406-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020406-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020406-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020406-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020406-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020406-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020406-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020406-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020406-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020406-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020406-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020406-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020406-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020406-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020406-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020406-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020406-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020406-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020406-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020406-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020406-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020406-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020406-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020406-002	AB	1	`a72a2bbeb626…`

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64764-541-30	EA - Each	64764-541	d3441685-1f25-4fc5-8be7-2ac185a693e4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	1000
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
methacrylic acid - ethyl acrylate copolymer (1:1) type A	INACTIVE INGREDIENT	NX76LV5T8J	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
PHENYLALANINE	INACTIVE INGREDIENT	47E5O17Y3R	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prevacid	LANSOPRAZOLE	Takeda Pharmaceuticals America, Inc.	71ba78cb-7e46-43eb-9425-fa130f537f84	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020406 application number: NDA020406

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	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
351260	lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet	PSN	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
596918	Prevacid 15 MG Delayed Release Oral Capsule	PSN	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
206206	Prevacid 30 MG Delayed Release Oral Capsule	PSN	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
206205	Prevacid SoluTab 15 MG Delayed Release Disintegrating Oral Tablet	PSN	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
866152	Prevacid SoluTab 30 MG Delayed Release Disintegrating Oral Tablet	PSN	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
596918	lansoprazole 15 MG Delayed Release Oral Capsule [Prevacid]	SBD	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
206205	lansoprazole 15 MG Disintegrating Oral Tablet [Prevacid]	SBD	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
206206	lansoprazole 30 MG Delayed Release Oral Capsule [Prevacid]	SBD	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
866152	lansoprazole 30 MG Disintegrating Oral Tablet [Prevacid]	SBD	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
351261	lansoprazole 15 MG Disintegrating Oral Tablet	SCD	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
351260	lansoprazole 30 MG Disintegrating Oral Tablet	SCD	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
351261	lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet	SY	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
351260	lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet	SY	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
206205	Prevacid 15 MG Delayed Release Disintegrating Oral Tablet	SY	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
596918	Prevacid 15 MG Delayed Release Oral Capsule	SY	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
866152	Prevacid 30 MG Delayed Release Disintegrating Oral Tablet	SY	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
206206	Prevacid 30 MG Delayed Release Oral Capsule	SY	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
206205	Prevacid SoluTab 15 MG Delayed Release Disintegrating Oral Tablet	SY	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2
866152	Prevacid SoluTab 30 MG Delayed Release Disintegrating Oral Tablet	SY	7140f8d9-e478-4f69-a4eb-3fd4c9414576	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64764-541-05	64764054105	5 BLISTER PACK in 1 TRAY (64764-541-05) > 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	5 blister pack	1995-05-10	0000-00-00	No	No	Current
64764-541-11	64764054111	10 BLISTER PACK in 1 CARTON (64764-541-11) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	10 blister pack	1995-05-10	0000-00-00	No	No	Current
64764-541-19	64764054119	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-541-19)		1995-05-10	0000-00-00	No	No	Current
64764-541-30	64764054130	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-541-30)		1995-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prevacid	Bryant Ranch Prepack	2015-04-28	HUMAN PRESCRIPTION DRUG LABEL	1000
Prevacid	Physicians Total Care, Inc.	2009-10-30	HUMAN PRESCRIPTION DRUG LABEL	2