Lansoprazole

Product NDC: 68001-112
11-digit product format: 680010112
Labeler code: 68001
Product ID: 68001-112_e1e35404-0cf3-e40d-e053-2995a90a3829
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA091269
Marketing category: ANDA
Marketing start: 2013-12-01
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 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…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311277	Internal RxNorm lookup
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
924c5a35-4804-4e14-a2fc-2b84d186d257	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
68001-112-03	Lansoprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	14
68001-112-04	Lansoprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	14
68001-112-05	Lansoprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
ammonia	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
methacrylic acid - ethyl acrylate copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
shellac	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
sucrose	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
talc	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
methacrylic acid - ethyl acrylate copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
shellac	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-112	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	14	Current NDC, Legacy NDC, 3 package rows	20220623_924c5a35-4804-4e14-a2fc-2b84d186d257.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 ndc (product): 68001-112
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	924c5a35-4804-4e14-a2fc-2b84d186d257	14
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	924c5a35-4804-4e14-a2fc-2b84d186d257	14
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	924c5a35-4804-4e14-a2fc-2b84d186d257	14
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	924c5a35-4804-4e14-a2fc-2b84d186d257	14
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	dee80a19-e514-41e6-9153-c959699d97b1	10
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	dee80a19-e514-41e6-9153-c959699d97b1	10
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	dee80a19-e514-41e6-9153-c959699d97b1	10
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	dee80a19-e514-41e6-9153-c959699d97b1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-112-03	68001011203	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-112-03)	2013-12-01	0000-00-00	No	No	Current
68001-112-04	68001011204	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-112-04)	2020-08-31	0000-00-00	No	No	Current
68001-112-05	68001011205	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-112-05)	2013-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole	American Health Packaging	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	10
Lansoprazole	BluePoint Laboratories \| Dr. Reddy's Laboratories Limited-FTOIII	2022-06-20	HUMAN PRESCRIPTION DRUG LABEL	14