Lansoprazole

Product NDC: 70700-263
11-digit product format: 707000263
Labeler code: 70700
Product ID: 70700-263_ce9167b4-3b92-9cbd-f4f5-a8788ed0d47a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Xiromed LLC
Application: ANDA203203
Marketing category: ANDA
Marketing start: 2018-08-24
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
A203203-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2016-07-25
A203203-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2016-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203203-001	AB
A203203-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A203203-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2016-07-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203203-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2016-07-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A203203-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203203-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Preferred Pharmaceuticals Inc.	db42468a-450c-4b12-b2f2-e9a76e976d45	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	3babf7d9-ad83-4e44-8e5d-f6c11b2d76b6	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	16dc1e02-4679-4d7f-a65b-6e3706655d35	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	37b221ee-b6a4-76e8-e063-6394a90a7e0b	2025-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	Golden State Medical Supply, Inc.	a9dd7e56-1aee-5f0b-e053-2995a90a43bf	2024-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	11344047-7ed4-61e7-e063-6394a90a332d	2024-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	e0299cf2-8a8e-499b-a81e-16e844ea3aff	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	ae03d05b-0a0f-4bae-bbdc-450b7b5f7a92	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	44f07613-35be-4673-98f0-4b2467acce9c	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	1dc026b6-b521-4a46-9a74-8c1c140d5329	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	a612a237-ec17-49f0-8985-44407608adb5	2023-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203
Lansoprazole	LANSOPRAZOLE	Xiromed LLC	00a574e0-bd03-deea-9f85-b108f78982ba	2022-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203203 application number: ANDA203203 ndc (product): 70700-263

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
00a574e0-bd03-deea-9f85-b108f78982ba	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	SPL version
70700-263-05	Lansoprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	22
70700-263-30	Lansoprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	22
70700-263-90	Lansoprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70700-263-05	EA - Each	70700-263	cad90b48-0c0f-40eb-84fa-b2a0ece12941	1	2017-08-11
70700-263-30	EA - Each	70700-263	ffbf39e2-43ec-4ec2-bb95-db79b01c4abb	1	2017-06-15
70700-263-90	EA - Each	70700-263	938097f9-9945-4597-ab42-1e74411fedd4	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70700-263	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [XIROMED LLC]	22	Current NDC, Legacy NDC, 3 package rows	20230707_00a574e0-bd03-deea-9f85-b108f78982ba.zip

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
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	ae03d05b-0a0f-4bae-bbdc-450b7b5f7a92	102
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	a612a237-ec17-49f0-8985-44407608adb5	102
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	1dc026b6-b521-4a46-9a74-8c1c140d5329	102
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	44f07613-35be-4673-98f0-4b2467acce9c	102
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	ae03d05b-0a0f-4bae-bbdc-450b7b5f7a92	102
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	a612a237-ec17-49f0-8985-44407608adb5	102
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	1dc026b6-b521-4a46-9a74-8c1c140d5329	102
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	44f07613-35be-4673-98f0-4b2467acce9c	102
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	e0299cf2-8a8e-499b-a81e-16e844ea3aff	100
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	e0299cf2-8a8e-499b-a81e-16e844ea3aff	100
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	00a574e0-bd03-deea-9f85-b108f78982ba	22
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	00a574e0-bd03-deea-9f85-b108f78982ba	22
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	00a574e0-bd03-deea-9f85-b108f78982ba	22
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	00a574e0-bd03-deea-9f85-b108f78982ba	22
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	a9dd7e56-1aee-5f0b-e053-2995a90a43bf	6
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	a9dd7e56-1aee-5f0b-e053-2995a90a43bf	6
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	3babf7d9-ad83-4e44-8e5d-f6c11b2d76b6	5
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	3babf7d9-ad83-4e44-8e5d-f6c11b2d76b6	5
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	db42468a-450c-4b12-b2f2-e9a76e976d45	3
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	db42468a-450c-4b12-b2f2-e9a76e976d45	3
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	37b221ee-b6a4-76e8-e063-6394a90a7e0b	1
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	16dc1e02-4679-4d7f-a65b-6e3706655d35	1
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	11344047-7ed4-61e7-e063-6394a90a332d	1
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	37b221ee-b6a4-76e8-e063-6394a90a7e0b	1
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	16dc1e02-4679-4d7f-a65b-6e3706655d35	1
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	11344047-7ed4-61e7-e063-6394a90a332d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70700-263-05	70700026305	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-263-05)	2018-08-24	0000-00-00	No	No	Current
70700-263-30	70700026330	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-263-30)	2018-08-24	0000-00-00	No	No	Current
70700-263-90	70700026390	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-263-90)	2018-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole	Preferred Pharmaceuticals Inc.	2026-05-18	HUMAN PRESCRIPTION DRUG LABEL	3
Lansoprazole	A-S Medication Solutions	2025-09-05	HUMAN PRESCRIPTION DRUG LABEL	5
Lansoprazole	A-S Medication Solutions	2025-09-05	HUMAN PRESCRIPTION DRUG LABEL	1
Lansoprazole	NuCare Pharmaceuticals,Inc.	2025-06-13	HUMAN PRESCRIPTION DRUG LABEL	1
Lansoprazole	Golden State Medical Supply, Inc.	2024-12-23	HUMAN PRESCRIPTION DRUG LABEL	6
Lansoprazole	NuCare Pharmaceuticals,Inc.	2024-02-12	HUMAN PRESCRIPTION DRUG LABEL	1
Lansoprazole	Bryant Ranch Prepack	2024-02-06	HUMAN PRESCRIPTION DRUG LABEL	100
Lansoprazole	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
Lansoprazole	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
Lansoprazole	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
Lansoprazole	Bryant Ranch Prepack	2023-11-14	HUMAN PRESCRIPTION DRUG LABEL	102
Lansoprazole	Xiromed LLC \| Xiromed Pharma Espana, S.L. \| Laboratorios Liconsa SAU	2022-04-15	HUMAN PRESCRIPTION DRUG LABEL	22