lansoprazole

Product NDC: 68382-543
11-digit product format: 683820543
Labeler code: 68382
Product ID: 68382-543_b828e447-56b6-4cab-bd49-053bcd4be948
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA202366
Marketing category: ANDA
Marketing start: 2013-08-23
Marketing end: 0000-00-00
Substance: LANSOPRAZOLE
Active strength: 15 mg/1
Pharmacologic classes: Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-543		D	Discontinued by firm	2026-08-17
excluded package	package	68382-543	68382-543-06	D	Discontinued by firm	2026-08-17
excluded package	package	68382-543	68382-543-10	D	Discontinued by firm	2026-08-17
excluded package	package	68382-543	68382-543-77	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 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	68382-543-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-543-77	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-543-10	`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	68382-543-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-543-77	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-543-10	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A202366-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2013-08-19
A202366-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2013-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202366-001	AB
A202366-002	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	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202366-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202366-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2013-08-19	`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	A202366-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202366-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202366-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202366-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202366-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202366-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202366-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202366-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202366-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202366-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202366-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202366-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202366-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202366-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202366-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202366-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202366-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202366-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202366-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202366-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202366-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202366-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202366-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202366-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202366-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202366-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202366-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202366-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202366-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202366-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202366-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202366-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202366-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202366-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202366-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202366-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202366-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202366-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202366-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202366-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-543-06	EA - Each	68382-543	147a1ae2-63fb-4656-99d9-0a1d58df1d69	1	2013-09-04
68382-543-10	EA - Each	68382-543	4b9d6adc-e14b-4d4c-b5a2-20f39256fd59	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
WATER	INACTIVE INGREDIENT	059QF0KO0R	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]	1000
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]	2
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [DIRECT RX]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K5C5T2QPG	LANSOPRAZOLE	103577-45-3	LANSOPRAZOLE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-543-06	68382054306	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68382-543-06)		2013-08-23	0000-00-00	No	No	Current
68382-543-10	68382054310	1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68382-543-10)		2013-08-23	0000-00-00	No	No	Current
68382-543-77	68382054377	10 BLISTER PACK in 1 CARTON (68382-543-77) > 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (68382-543-30)	10 blister pack	2013-08-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
lansoprazole	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2022-11-10	HUMAN PRESCRIPTION DRUG LABEL	11
lansoprazole	Bryant Ranch Prepack	2022-02-08	HUMAN PRESCRIPTION DRUG LABEL	1001
lansoprazole	AvPAK	2021-02-01	HUMAN PRESCRIPTION DRUG LABEL	5
LANSOPRAZOLE	Direct RX	2019-04-17	HUMAN PRESCRIPTION DRUG LABEL	3