LANSOPRAZOLE

Product NDC: 61919-245
11-digit product format: 619190245
Labeler code: 61919
Product ID: 61919-245_94908284-aad8-7b83-e053-2995a90a12c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LANSOPRAZOLE
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: DIRECT RX
Application: ANDA091269
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: LANSOPRAZOLE
Active strength: 15 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-245		I	Inactivated by FDA	2026-08-03
excluded package	package	61919-245	61919-245-30	I	Inactivated by FDA	2026-08-03
excluded package	package	61919-245	61919-245-60	I	Inactivated by FDA	2026-08-03

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 · 45 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	61919-245-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-245-60	`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	61919-245-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-245-60	`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	61919-245-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-245-60	`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	61919-245-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-245-60	`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	61919-245-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-245-60	`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	61919-245-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-245-60	`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	61919-245-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-245-60	`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	61919-245-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-245-60	`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	61919-245-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-245-60	`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	61919-245-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-245-60	`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	61919-245-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-245-60	`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	61919-245-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-245-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-245-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-245-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-245-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-245-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-245-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-245-60	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091269-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2010-10-15
A091269-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2010-10-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091269-001	AB
A091269-002	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 · 82 observed 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
2026-02-19 14:30 UTC	2026-02	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2010-10-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091269-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091269-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091269-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091269-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091269-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091269-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091269-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091269-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091269-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091269-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091269-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091269-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091269-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091269-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091269-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091269-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091269-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091269-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091269-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091269-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091269-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091269-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091269-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091269-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091269-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091269-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091269-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091269-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091269-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091269-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091269-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091269-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091269-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091269-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091269-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091269-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091269-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091269-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091269-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091269-002	AB	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-245-30	2023-01-30	C162847	48780-1	f386c649-adea-0266-e053-dadaa90a7c1a	LANSOPRAZOLE
61919-245-60	2023-01-30	C162847	48780-1	f386c649-adea-0266-e053-dadaa90a7c1a	LANSOPRAZOLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-245-30	LANSOPRAZOLE	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		5
61919-245-60	LANSOPRAZOLE	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-245-30	EA - Each	61919-245	550d363e-2cad-4b16-8c4e-ff2ae163a78a	1	2015-08-04
61919-245-60	EA - Each	61919-245	1d0bb0b7-b901-4f33-b0e4-7d558c8461d7	1	2019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
methacrylic acid - ethyl acrylate copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
shellac	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-245	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	5	Legacy NDC, 2 package rows	20191126_e55d3f85-a6f2-42ff-a83d-645743c7cc6b.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Redpharm Drug	56cafcf5-ce3d-a312-e063-6294a90a3db1	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Major Pharmaceuticals	854e4235-4815-4461-9b9b-d3d783fb775d	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Preferred Pharmaceuticals Inc.	960d6601-aec5-4900-a400-385b6687a4bc	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	e7a3aa37-9c9b-43fe-92be-6e0fdc8d1c92	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	American Health Packaging	dee80a19-e514-41e6-9153-c959699d97b1	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole DR	LANSOPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	c77da981-9260-fabd-e053-2a95a90aa71c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	22f416bf-00f1-ceb9-e063-6394a90aa1dd	2024-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	e07c7445-9652-4833-8b17-45c0124c4e5d	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	6d81faf7-aa59-429c-e053-2a91aa0a8bb2	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	12b2e59b-2b7a-4d22-ad9b-9a7d9a5264bd	2023-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Proficient Rx LP	3e3e63df-e2ad-420b-acb9-28e65ea6fb07	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	BluePoint Laboratories	924c5a35-4804-4e14-a2fc-2b84d186d257	2022-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Dr.Reddy's Laboratories Ltd.	82174fcc-1b0f-2068-7fc4-db335b43b5e2	2022-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269

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	e55d3f85-a6f2-42ff-a83d-645743c7cc6b	5
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	e55d3f85-a6f2-42ff-a83d-645743c7cc6b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-245-30	61919024530	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-245-30)	2014-01-01	0000-00-00	No	No	Current
61919-245-60	61919024560	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-245-60)	2014-01-01	0000-00-00	No	No	Current