Lansoprazole

Product NDC: 55111-398
11-digit product format: 551110398
Labeler code: 55111
Product ID: 55111-398_c8eb1d41-1fd2-7c06-486c-e6abf08faa6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Dr.Reddy's Laboratories Ltd.
Application: ANDA091269
Marketing category: ANDA
Marketing start: 2010-10-15
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: 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	15 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
82174fcc-1b0f-2068-7fc4-db335b43b5e2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
55111-398-01	Lansoprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	28
55111-398-05	Lansoprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	28
55111-398-30	Lansoprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	28
55111-398-60	Lansoprazole	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	28
55111-398-79	Lansoprazole	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	28
55111-398-79	Lansoprazole	10 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	10	28
55111-398-90	Lansoprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-398-30	EA - Each	55111-398	6bad8a1b-5e4c-408f-b16e-593e918a683a	1	2012-07-24
55111-398-90	EA - Each	55111-398	73191f0c-4070-4163-861c-6f205b57e490	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
ammonia	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
gelatin	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
Hydroxypropyl Cellulose (Type H)	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
methacrylic acid - ethyl acrylate copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
shellac	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
sucrose	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
talc	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	18
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	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
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	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
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
methacrylic acid - ethyl acrylate copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
methacrylic acid - ethyl acrylate copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
methacrylic acid - ethyl acrylate copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	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
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
shellac	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
shellac	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
shellac	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-398	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]	28	Current NDC, Legacy NDC, 7 package rows	20220525_82174fcc-1b0f-2068-7fc4-db335b43b5e2.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 ndc (product): 55111-398

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	e7a3aa37-9c9b-43fe-92be-6e0fdc8d1c92	100
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	e7a3aa37-9c9b-43fe-92be-6e0fdc8d1c92	100
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	82174fcc-1b0f-2068-7fc4-db335b43b5e2	28
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	82174fcc-1b0f-2068-7fc4-db335b43b5e2	28
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	82174fcc-1b0f-2068-7fc4-db335b43b5e2	28
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	82174fcc-1b0f-2068-7fc4-db335b43b5e2	28
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	e07c7445-9652-4833-8b17-45c0124c4e5d	18
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	e07c7445-9652-4833-8b17-45c0124c4e5d	18
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	960d6601-aec5-4900-a400-385b6687a4bc	9
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	960d6601-aec5-4900-a400-385b6687a4bc	9
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	c77da981-9260-fabd-e053-2a95a90aa71c	6
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	c77da981-9260-fabd-e053-2a95a90aa71c	6
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
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	6d81faf7-aa59-429c-e053-2a91aa0a8bb2	4
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	6d81faf7-aa59-429c-e053-2a91aa0a8bb2	4
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	7dcbbe7b-4eda-440a-e053-2a91aa0a41c1	2
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	7dcbbe7b-4eda-440a-e053-2a91aa0a41c1	2
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	22f416bf-00f1-ceb9-e063-6394a90aa1dd	1
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	152fb727-d516-441e-a72b-33ddf1a325c1	1
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	152fb727-d516-441e-a72b-33ddf1a325c1	1
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	22f416bf-00f1-ceb9-e063-6394a90aa1dd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-398-01	55111039801	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-398-01)		2010-10-15	0000-00-00	No	No	Current
55111-398-05	55111039805	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-398-05)		2010-10-15	0000-00-00	No	No	Current
55111-398-30	55111039830	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-398-30)		2010-10-15	0000-00-00	No	No	Current
55111-398-60	55111039860	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-398-60)		2010-10-15	0000-00-00	No	No	Current
55111-398-79	55111039879	1 BLISTER PACK in 1 CARTON (55111-398-79) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	1 blister pack	2010-10-15	0000-00-00	No	No	Current
55111-398-90	55111039890	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-398-90)		2010-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole	Preferred Pharmaceuticals Inc.	2026-01-12	HUMAN PRESCRIPTION DRUG LABEL	9
Lansoprazole	Bryant Ranch Prepack	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	100
Lansoprazole DR Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Lansoprazole	NuCare Pharmaceuticals,Inc.	2024-09-25	HUMAN PRESCRIPTION DRUG LABEL	1
Lansoprazole	Bryant Ranch Prepack	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	18
Lansoprazole	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	4
Lansoprazole	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2023-12-13	HUMAN PRESCRIPTION DRUG LABEL	10
Lansoprazole	Bryant Ranch Prepack	2022-06-28	HUMAN PRESCRIPTION DRUG LABEL	6
Lansoprazole	Dr.Reddy's Laboratories Ltd. \| Dr. Reddy's Laboratories Limited-FTOIII	2022-03-21	HUMAN PRESCRIPTION DRUG LABEL	28
LANSOPRAZOLE	DIRECT RX	2019-10-10	HUMAN PRESCRIPTION DRUG LABEL	5
Lansoprazole	medsource pharmaceuticals	2018-12-24	HUMAN PRESCRIPTION DRUG LABEL	2
Lansoprazole	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-10-16	HUMAN PRESCRIPTION DRUG LABEL	1