Lansoprazole

Product NDC: 27241-020
11-digit product format: 272410020
Labeler code: 27241
Product ID: 27241-020_1e0a31f6-b245-43a0-81f4-8654c4b381d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Ajanta Pharma USA Inc.
Application: ANDA203957
Marketing category: ANDA
Marketing start: 2016-10-18
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 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
A203957-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL			2016-10-14
A203957-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL			2016-10-14

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203957-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203957-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	2016-10-14	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A203957-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203957-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203957-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203957-002	AB	1	`ea99ee380514…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311277	Internal RxNorm lookup
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
6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
d6b97638-59f4-48e2-8959-569628732c46	Product name	9	20210622
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
27241-020-03	Lansoprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	17
27241-020-09	Lansoprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	17
27241-020-10	Lansoprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	17
27241-020-50	Lansoprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	17
27241-020-90	Lansoprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27241-020-03	EA - Each	27241-020	8d8f6705-fc3a-4aa4-ae7b-94d7c90b491d	1	2017-06-15
27241-020-09	EA - Each	27241-020	8524c4c1-32ed-40ed-8a3a-b79ee3b433a9	1	2017-06-15
27241-020-50	EA - Each	27241-020	c444c963-8e05-4e72-bda7-96136e1c6c5f	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27241-020	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AJANTA PHARMA USA INC.]	16	Current NDC, Legacy NDC, 5 package rows	20250418_6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b.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	Ajanta Pharma USA Inc.	6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203957 application number: ANDA203957 ndc (product): 27241-020

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	6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b	17
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b	17
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b	17
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	6b9c60e9-b0d2-4aec-a04b-ccc7a62c822b	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
27241-020-03	27241002003	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-020-03)	2016-10-18	0000-00-00	No	No	Current
27241-020-09	27241002009	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-020-09)	2016-10-18	0000-00-00	No	No	Current
27241-020-10	27241002010	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-020-10)	2016-10-18	0000-00-00	No	No	Current
27241-020-50	27241002050	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-020-50)	2016-10-18	0000-00-00	No	No	Current
27241-020-90	27241002090	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (27241-020-90)	2016-10-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole	Ajanta Pharma USA Inc. \| Ajanta Pharma Limited, Paithan	2025-11-10	Human Prescription Drug Label	17