Lansoprazole

Product NDC: 16714-186
11-digit product format: 167140186
Labeler code: 16714
Product ID: 16714-186_1e12b24b-c259-7423-cf4a-494d2fbe098b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lansoprazole
Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA210465
Marketing category: ANDA
Marketing start: 2021-12-10
Marketing end: 2026-09-30
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
A210465-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB		2021-02-01
A210465-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB		2021-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210465-001	AB
A210465-002	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 · 70 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
2026-02-19 14:30 UTC	2026-02	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210465-001	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210465-002	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	2021-02-01	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210465-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210465-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210465-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210465-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210465-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210465-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210465-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210465-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210465-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210465-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210465-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210465-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210465-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210465-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210465-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210465-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210465-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210465-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210465-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210465-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210465-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210465-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210465-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210465-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210465-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210465-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210465-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210465-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210465-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210465-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210465-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210465-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210465-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210465-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210465-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210465-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210465-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210465-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210465-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210465-002	AB	1	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lansoprazole

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
4c7cc078-09de-f4fc-d111-1248f2261d17	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
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	Strength	SPL version
16714-186-01	Lansoprazole	10 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING, D	10		3
16714-186-02	Lansoprazole	100 in 1 CARTON	TABLET, ORALLY DISINTEGRATING, D	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-186-01	EA - Each	16714-186	49e7c17d-ba2d-4f48-a32e-4ac4a2fe9d4a	1	2022-03-09
16714-186-02	EA - Each	16714-186	e390c913-f634-463f-930e-041e2569093f	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-186	LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [NORTHSTAR RX LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231020_4c7cc078-09de-f4fc-d111-1248f2261d17.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	Dr.Reddys Laboratories Inc	656bc92a-1f95-047d-cd27-724073e63fe6	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210465 application number: ANDA210465
Lansoprazole	LANSOPRAZOLE	NorthStar Rx LLC	4c7cc078-09de-f4fc-d111-1248f2261d17	2023-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210465 application number: ANDA210465 ndc (product): 16714-186

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	4c7cc078-09de-f4fc-d111-1248f2261d17	3
351260	lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet	PSN	4c7cc078-09de-f4fc-d111-1248f2261d17	3
351261	lansoprazole 15 MG Disintegrating Oral Tablet	SCD	4c7cc078-09de-f4fc-d111-1248f2261d17	3
351260	lansoprazole 30 MG Disintegrating Oral Tablet	SCD	4c7cc078-09de-f4fc-d111-1248f2261d17	3
351261	lansoprazole 15 MG Delayed Release Disintegrating Oral Tablet	SY	4c7cc078-09de-f4fc-d111-1248f2261d17	3
351260	lansoprazole 30 MG Delayed Release Disintegrating Oral Tablet	SY	4c7cc078-09de-f4fc-d111-1248f2261d17	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-186-01	16714018601	10 in 1 BLISTER PACK						Historical
16714-186-02	16714018602	100 BLISTER PACK in 1 CARTON (16714-186-02) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (16714-186-01)	100 blister pack	2021-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole	NorthStar Rx LLC \| DR. REDDY'S LABORATORIES LIMITED (FTO-Sez-Process Unit-01)	2023-07-15	HUMAN PRESCRIPTION DRUG LABEL	4