Lansoprazole

Product NDC: 68001-112
Requested package NDC: 68001-112-04
11-digit product format: 680010112
Labeler code: 68001
Product ID: 68001-112_e1e35404-0cf3-e40d-e053-2995a90a3829
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA091269
Marketing category: ANDA
Marketing start: 2013-12-01
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
A091269-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2010-10-15
A091269-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2010-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091269-001	AB
A091269-002	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	A091269-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2010-10-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091269-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2010-10-15	`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	A091269-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091269-002	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Redpharm Drug	56cafcf5-ce3d-a312-e063-6294a90a3db1	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Major Pharmaceuticals	854e4235-4815-4461-9b9b-d3d783fb775d	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Preferred Pharmaceuticals Inc.	960d6601-aec5-4900-a400-385b6687a4bc	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	e7a3aa37-9c9b-43fe-92be-6e0fdc8d1c92	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	American Health Packaging	dee80a19-e514-41e6-9153-c959699d97b1	2025-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole DR	LANSOPRAZOLE	Advanced Rx Pharmacy of Tennessee, LLC	c77da981-9260-fabd-e053-2a95a90aa71c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	22f416bf-00f1-ceb9-e063-6394a90aa1dd	2024-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Bryant Ranch Prepack	e07c7445-9652-4833-8b17-45c0124c4e5d	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	6d81faf7-aa59-429c-e053-2a91aa0a8bb2	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	A-S Medication Solutions	12b2e59b-2b7a-4d22-ad9b-9a7d9a5264bd	2023-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	Proficient Rx LP	3e3e63df-e2ad-420b-acb9-28e65ea6fb07	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269
Lansoprazole	LANSOPRAZOLE	BluePoint Laboratories	924c5a35-4804-4e14-a2fc-2b84d186d257	2022-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269 ndc (package): 68001-112-04 ndc (product): 68001-112 ndc11 (package): 68001011204
Lansoprazole	LANSOPRAZOLE	Dr.Reddy's Laboratories Ltd.	82174fcc-1b0f-2068-7fc4-db335b43b5e2	2022-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091269 application number: ANDA091269

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
924c5a35-4804-4e14-a2fc-2b84d186d257	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	SPL version
68001-112-03	Lansoprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	14
68001-112-04	Lansoprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	14
68001-112-05	Lansoprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
ammonia	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
methacrylic acid - ethyl acrylate copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
shellac	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
sucrose	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
talc	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	3
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
methacrylic acid - ethyl acrylate copolymer (1:1) Type A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
raw sugar	INACTIVE INGREDIENT	8M707QY5GH	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
shellac	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-112	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BLUEPOINT LABORATORIES]	14	Current NDC, Legacy NDC, 3 package rows	20220623_924c5a35-4804-4e14-a2fc-2b84d186d257.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
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	924c5a35-4804-4e14-a2fc-2b84d186d257	14
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	924c5a35-4804-4e14-a2fc-2b84d186d257	14
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	924c5a35-4804-4e14-a2fc-2b84d186d257	14
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	924c5a35-4804-4e14-a2fc-2b84d186d257	14
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	dee80a19-e514-41e6-9153-c959699d97b1	10
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	dee80a19-e514-41e6-9153-c959699d97b1	10
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	dee80a19-e514-41e6-9153-c959699d97b1	10
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	dee80a19-e514-41e6-9153-c959699d97b1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-112-04	68001011204	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68001-112-04)	2020-08-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole	American Health Packaging	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	10
Lansoprazole	BluePoint Laboratories \| Dr. Reddy's Laboratories Limited-FTOIII	2022-06-20	HUMAN PRESCRIPTION DRUG LABEL	14