Lansoprazole

Product NDC: 55154-8340
11-digit product format: 551548340
Labeler code: 55154
Product ID: 55154-8340_7daa1721-f92b-4096-b19e-4d27fc8acb51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lansoprazole
Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA207167
Marketing category: ANDA
Marketing start: 2026-08-24
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: 2027-12-31
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
A207167-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB		2023-03-28
A207167-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB		2023-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207167-001	AB
A207167-002	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 · 50 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	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207167-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207167-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2023-03-28	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 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	A207167-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207167-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207167-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207167-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207167-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207167-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207167-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207167-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207167-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207167-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207167-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207167-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207167-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207167-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207167-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207167-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207167-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207167-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207167-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207167-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207167-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207167-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207167-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207167-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207167-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207167-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207167-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207167-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207167-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207167-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207167-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207167-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207167-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207167-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207167-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207167-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207167-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207167-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207167-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207167-002	AB	1	`a72a2bbeb626…`

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: 2027-12-31

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
351260	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
7daa1721-f92b-4096-b19e-4d27fc8acb51	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Cardinal Health 107, LLC	7daa1721-f92b-4096-b19e-4d27fc8acb51	2026-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207167 application number: ANDA207167 ndc (product): 55154-8340
Lansoprazole	LANSOPRAZOLE	NorthStar Rx LLC	ac051296-6fe3-4ab5-a001-cc3e06199a22	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207167 application number: ANDA207167
Lansoprazole	LANSOPRAZOLE	Aurobindo Pharma Limited	1f2883d8-12db-40b7-9104-22a6690a22a7	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207167 application number: ANDA207167

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	Sample	Exclude flag	Status
55154-8340-0	55154834000	1 BLISTER PACK in 1 BAG (55154-8340-0) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK	1 blister pack	2026-08-24	No	No	Current