Lansoprazole

Product NDC: 69842-755
11-digit product format: 698420755
Labeler code: 69842
Product ID: 69842-755_c51f66b9-1b2c-4730-81c3-63d58e939862
Type: HUMAN OTC DRUG
Nonproprietary name: Lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: CVS Pharmacy
Application: ANDA203187
Marketing category: ANDA
Marketing start: 2019-03-31
Marketing end: 2026-12-31
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
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203187-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL			2016-06-01

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203187-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-06-01	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lansoprazole

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
d52b26e2-3d2a-4067-a28b-8697f865f582	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69842-755-14	2020-10-26	DRUG FACTS
69842-755-28	2020-10-26	DRUG FACTS
69842-755-42	2020-10-26	DRUG FACTS
69842-755-14	2020-09-27	DRUG FACTS
69842-755-28	2020-09-27	DRUG FACTS
69842-755-42	2020-09-27	DRUG FACTS
69842-755-14	2020-09-25	DRUG FACTS
69842-755-28	2020-09-25	DRUG FACTS
69842-755-42	2020-09-25	DRUG FACTS
69842-755-14	2020-07-22	DRUG FACTS
69842-755-28	2020-07-22	DRUG FACTS
69842-755-42	2020-07-22	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69842-755-14	Lansoprazole	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	4
69842-755-14	Lansoprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	4
69842-755-28	Lansoprazole	2 in 1 BOX	CAPSULE, DELAYED RELEASE	2	4
69842-755-28	Lansoprazole	14 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	14	4
69842-755-42	Lansoprazole	14 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	14	4
69842-755-42	Lansoprazole	3 in 1 BOX	CAPSULE, DELAYED RELEASE	3	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-755	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [CVS PHARMACY]	3	Current NDC, Legacy NDC, 6 package rows	20221123_d52b26e2-3d2a-4067-a28b-8697f865f582.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Rite Aid Corporation	5f256a0c-14df-4fd9-a818-b4276954152e	2025-08-25	Warnings	Exact identifier application applno (ANDA): 203187 application number: ANDA203187
Lansoprazole	LANSOPRAZOLE	CVS Pharmacy	d52b26e2-3d2a-4067-a28b-8697f865f582	2025-08-20	Warnings	Exact identifier application applno (ANDA): 203187 application number: ANDA203187 ndc (product): 69842-755

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	d52b26e2-3d2a-4067-a28b-8697f865f582	4
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	d52b26e2-3d2a-4067-a28b-8697f865f582	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-755-14	69842075514	1 BOTTLE in 1 CARTON (69842-755-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	1 bottle	2019-03-31	2026-12-31	No	No	Current
69842-755-28	69842075528	2 BOTTLE, PLASTIC in 1 BOX (69842-755-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC		2019-03-31	2026-12-31	No	No	Current
69842-755-42	69842075542	3 BOTTLE, PLASTIC in 1 BOX (69842-755-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC		2019-03-31	2026-12-31	No	No	Current