Lansoprazole

Product NDC: 68071-3585
11-digit product format: 680713585
Labeler code: 68071
Product ID: 68071-3585_136afc4c-877f-e9b5-e063-6394a90a75c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA201921
Marketing category: ANDA
Marketing start: 2020-01-11
Substance: LANSOPRAZOLE
Active strength: 30 mg/1
Pharmacologic classes: Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 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
A201921-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2012-12-18
A201921-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2012-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201921-001	AB
A201921-002	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 · 86 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	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A201921-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201921-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201921-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201921-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201921-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201921-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201921-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201921-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201921-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201921-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201921-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201921-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201921-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201921-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201921-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201921-002	AB	1	`74a2ff9319b5…`

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	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0K5C5T2QPG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311277	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
136ad992-2e39-dad9-e063-6294a90adcc6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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	Strength	SPL version
68071-3585-3	Lansoprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3585	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]	1	Current NDC, 1 package rows	20240313_136ad992-2e39-dad9-e063-6294a90adcc6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	136ad992-2e39-dad9-e063-6294a90adcc6	2024-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201921 application number: ANDA201921 ndc (product): 68071-3585

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	136ad992-2e39-dad9-e063-6294a90adcc6	1
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	136ad992-2e39-dad9-e063-6294a90adcc6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3585-3	68071358503	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3585-3)	2024-03-11	No	No	Current