Lansoprazole

Product NDC: 71335-9693
Requested package NDC: 71335-9693-4
11-digit product format: 713359693
Labeler code: 71335
Product ID: 71335-9693_7314235c-0007-4d48-a641-1866850b49ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203083
Marketing category: ANDA
Marketing start: 2020-05-18
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 43.

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
A203083-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-05-18
A203083-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203083-001	AB
A203083-002	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 2 · 78 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
2026-09-14 22:38:34	2026-08	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203083-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203083-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-05-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203083-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203083-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203083-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203083-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203083-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203083-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203083-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203083-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203083-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203083-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203083-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203083-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203083-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203083-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203083-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203083-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203083-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203083-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203083-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203083-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203083-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203083-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203083-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203083-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203083-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203083-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203083-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203083-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203083-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203083-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203083-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203083-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203083-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203083-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203083-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203083-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203083-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203083-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203083-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203083-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
33fc642c-ad41-410b-9a81-eae456f3fcfb	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
71335-9693-1	Lansoprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	100
71335-9693-2	Lansoprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	100
71335-9693-3	Lansoprazole	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	100
71335-9693-4	Lansoprazole	58 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	58	100
71335-9693-5	Lansoprazole	28 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	28	100
71335-9693-6	Lansoprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	100
71335-9693-7	Lansoprazole	120 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	120	100
71335-9693-8	Lansoprazole	180 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	180	100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-9693	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	100	Current NDC, 8 package rows	20230421_33fc642c-ad41-410b-9a81-eae456f3fcfb.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	dfdc9aa0-8612-9127-e053-2a95a90ae7c8	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203083 application number: ANDA203083
Lansoprazole	LANSOPRAZOLE	Quallent Pharmaceuticals Health LLC	cc006372-32d3-4539-921a-6bc9ec496b28	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203083 application number: ANDA203083
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	1bbb8f3a-80bf-b881-e063-6294a90ab4f2	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203083 application number: ANDA203083
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	33fc642c-ad41-410b-9a81-eae456f3fcfb	2023-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203083 application number: ANDA203083 ndc (package): 71335-9693-4 ndc (product): 71335-9693 ndc11 (package): 71335969304
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	551ae468-1a2d-43d6-a2a8-4e5f26e0f982	2023-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203083 application number: ANDA203083
Lansoprazole	LANSOPRAZOLE	Camber Pharmaceuticals, Inc.	03b7dceb-2128-4324-b068-7f76a2d9887e	2020-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203083 application number: ANDA203083

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	33fc642c-ad41-410b-9a81-eae456f3fcfb	100
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	33fc642c-ad41-410b-9a81-eae456f3fcfb	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-9693-4	71335969304	58 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-9693-4)	2023-04-18	No	No	Current