Lansoprazole

Product NDC: 0378-6982
11-digit product format: 003786982
Labeler code: 0378
Product ID: 0378-6982_00959575-41db-4810-b59c-1edd08568b17
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lansoprazole
Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA202396
Marketing category: ANDA
Marketing start: 2018-11-29
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 44.

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
A202396-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB		2018-11-28
A202396-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB		2018-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202396-001	AB
A202396-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202396-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202396-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-28	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202396-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202396-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202396-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202396-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202396-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202396-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202396-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202396-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202396-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202396-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202396-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202396-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202396-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202396-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202396-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202396-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202396-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202396-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202396-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202396-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202396-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202396-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202396-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202396-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202396-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202396-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202396-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202396-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202396-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202396-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202396-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202396-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202396-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202396-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202396-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202396-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202396-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202396-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202396-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202396-002	AB	1	`3a93d1ddd44b…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351260	Internal RxNorm lookup
351261	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
20ff347c-ca18-497b-948d-1145035f2ffc	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0378-6982-32	Lansoprazole	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING, D	10	5
0378-6982-85	Lansoprazole	5 in 1 CARTON	TABLET, ORALLY DISINTEGRATING, D	5	5
0378-6982-88	Lansoprazole	2 in 1 BOX	TABLET, ORALLY DISINTEGRATING, D	2	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-6982-32	EA - Each	0378-6982	a648cd8c-74ea-4709-a9f1-752e9f7f2ed5	1	2018-12-13
0378-6982-85	EA - Each	0378-6982	d5afe7ea-e099-489b-be8b-98d47a78528c	1	2021-11-09
0378-6982-88	EA - Each	0378-6982	859f6882-1ac1-4931-a0ed-db57e74f29d0	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-6982	LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	5	Current NDC, Legacy NDC, 3 package rows	20240330_20ff347c-ca18-497b-948d-1145035f2ffc.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	Mylan Pharmaceuticals Inc.	20ff347c-ca18-497b-948d-1145035f2ffc	2024-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202396 application number: ANDA202396 ndc (product): 0378-6982

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
351261	lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet	PSN	20ff347c-ca18-497b-948d-1145035f2ffc	5
351260	lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet	PSN	20ff347c-ca18-497b-948d-1145035f2ffc	5
351261	lansoprazole 15 MG Disintegrating Oral Tablet	SCD	20ff347c-ca18-497b-948d-1145035f2ffc	5
351260	lansoprazole 30 MG Disintegrating Oral Tablet	SCD	20ff347c-ca18-497b-948d-1145035f2ffc	5
351261	lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet	SY	20ff347c-ca18-497b-948d-1145035f2ffc	5
351260	lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet	SY	20ff347c-ca18-497b-948d-1145035f2ffc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-6982-32	00378698232	10 in 1 BLISTER PACK						Historical
0378-6982-85	00378698285	5 in 1 CARTON						Historical
0378-6982-88	00378698288	2 CARTON in 1 BOX (0378-6982-88) / 5 BLISTER PACK in 1 CARTON (0378-6982-85) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (0378-6982-32)	2 carton	2018-11-29	0000-00-00	No	No	Current