LANSOPRAZOLE

Product NDC: 68382-771
11-digit product format: 683820771
Labeler code: 68382
Product ID: 68382-771_3de4f129-dc87-48e1-b934-b2a038df8cf7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LANSOPRAZOLE
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA200816
Marketing category: ANDA
Marketing start: 2018-11-30
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
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
A200816-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB		2018-11-27
A200816-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB		2018-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200816-001	AB
A200816-002	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	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200816-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200816-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2018-11-27	`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	A200816-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200816-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200816-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200816-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200816-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200816-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200816-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200816-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200816-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200816-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200816-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200816-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200816-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200816-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200816-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200816-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200816-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200816-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200816-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200816-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200816-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200816-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200816-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200816-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200816-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200816-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200816-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200816-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200816-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200816-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200816-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200816-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200816-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200816-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200816-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200816-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200816-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200816-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200816-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200816-002	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	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 · 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
9b3869ad-f2f7-4954-b75c-5c23b8951635	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68382-771-30	LANSOPRAZOLE	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	10		6
68382-771-77	LANSOPRAZOLE	10 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-771-30	EA - Each	68382-771	293af7c0-cf6c-439c-a1bc-11adbc9a50a6	1	2019-01-24
68382-771-77	EA - Each	68382-771	ea1e2abb-51b9-4e3f-aa80-b1d7e3c98198	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-771	LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING [ZYDUS PHARMACEUTICALS USA INC.]	6	Current NDC, Legacy NDC, 2 package rows	20220825_9b3869ad-f2f7-4954-b75c-5c23b8951635.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	Zydus Lifesciences Limited	76ffd38e-bea8-45a0-b6bd-82f0043ce64d	2024-11-30		Exact identifier application applno (ANDA): 200816 application number: ANDA200816
LANSOPRAZOLE	LANSOPRAZOLE	Zydus Pharmaceuticals USA Inc.	9b3869ad-f2f7-4954-b75c-5c23b8951635	2022-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200816 application number: ANDA200816 ndc (product): 68382-771

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	9b3869ad-f2f7-4954-b75c-5c23b8951635	6
351260	lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet	PSN	9b3869ad-f2f7-4954-b75c-5c23b8951635	6
351261	lansoprazole 15 MG Disintegrating Oral Tablet	SCD	9b3869ad-f2f7-4954-b75c-5c23b8951635	6
351260	lansoprazole 30 MG Disintegrating Oral Tablet	SCD	9b3869ad-f2f7-4954-b75c-5c23b8951635	6
351261	lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet	SY	9b3869ad-f2f7-4954-b75c-5c23b8951635	6
351260	lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet	SY	9b3869ad-f2f7-4954-b75c-5c23b8951635	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-771-30	68382077130	10 in 1 BLISTER PACK						Historical
68382-771-77	68382077177	10 BLISTER PACK in 1 CARTON (68382-771-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-771-30)	10 blister pack	2018-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LANSOPRAZOLE	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2022-08-22	HUMAN PRESCRIPTION DRUG LABEL	6