Lansoprazole

Product NDC: 63187-152
11-digit product format: 631870152
Labeler code: 63187
Product ID: 63187-152_0ca90194-0255-4661-896a-e066e593bf8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077255
Marketing category: ANDA
Marketing start: 2009-11-11
Substance: LANSOPRAZOLE
Active strength: 30 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 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
A077255-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-11-10
A077255-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077255-001	AB
A077255-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A077255-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077255-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077255-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077255-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077255-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077255-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077255-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077255-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077255-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077255-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077255-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077255-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077255-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077255-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077255-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077255-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077255-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077255-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077255-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077255-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077255-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077255-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077255-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077255-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077255-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077255-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077255-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077255-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077255-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077255-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077255-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077255-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077255-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077255-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077255-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077255-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077255-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077255-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077255-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077255-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LANSOPRAZOLE	30 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
311277	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
7d811f01-f0c2-4753-bb36-80b48dabb58c	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
63187-152-30	Lansoprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-152-30	EA - Each	63187-152	35b4fcd3-5702-4d67-b62c-d93a0979b08e	1	2016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-152	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 1 package rows	20210121_7d811f01-f0c2-4753-bb36-80b48dabb58c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Teva Pharmaceuticals USA, Inc.	427cf924-be17-47dc-8f77-115fa2f3fe17	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077255 application number: ANDA077255
Lansoprazole	LANSOPRAZOLE	Proficient Rx LP	7d811f01-f0c2-4753-bb36-80b48dabb58c	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077255 application number: ANDA077255 ndc (product): 63187-152

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
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	7d811f01-f0c2-4753-bb36-80b48dabb58c	3
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	7d811f01-f0c2-4753-bb36-80b48dabb58c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-152-30	63187015230	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-152-30)	2019-01-01	0000-00-00	No	No	Current