Lansoprazole

Product NDC: 0093-7350
11-digit product format: 000937350
Labeler code: 0093
Product ID: 0093-7350_cff4a734-b698-4be2-88f2-058914575919
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA077255
Marketing category: ANDA
Marketing start: 2009-11-11
Marketing end: 2027-07-31
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 42.

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
A077255-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-11-10
A077255-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2009-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077255-001	AB
A077255-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077255-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077255-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-11-10	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077255-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077255-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077255-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077255-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077255-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077255-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077255-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077255-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077255-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077255-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077255-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077255-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077255-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077255-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077255-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077255-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077255-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077255-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077255-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077255-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077255-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077255-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077255-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077255-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077255-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077255-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077255-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077255-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077255-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077255-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077255-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077255-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077255-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077255-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077255-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077255-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077255-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077255-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077255-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077255-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lansoprazole

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
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
427cf924-be17-47dc-8f77-115fa2f3fe17	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
0093-7350-56	Lansoprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7350-56	EA - Each	0093-7350	d56d5cfa-6310-4762-88f8-125893b9da27	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	14
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	4
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	LANSOPRAZOLE (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [AVKARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-7350	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [TEVA PHARMACEUTICALS USA, INC.]	25	Current NDC, Legacy NDC, 1 package rows	20220626_427cf924-be17-47dc-8f77-115fa2f3fe17.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	Teva Pharmaceuticals USA, Inc.	427cf924-be17-47dc-8f77-115fa2f3fe17	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077255 application number: ANDA077255 ndc (product): 0093-7350
Lansoprazole	LANSOPRAZOLE	Proficient Rx LP	7d811f01-f0c2-4753-bb36-80b48dabb58c	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077255 application number: ANDA077255

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	427cf924-be17-47dc-8f77-115fa2f3fe17	25
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	427cf924-be17-47dc-8f77-115fa2f3fe17	25
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	427cf924-be17-47dc-8f77-115fa2f3fe17	25
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	427cf924-be17-47dc-8f77-115fa2f3fe17	25
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	e33ac27f-43ae-4912-8e41-626091fc5ad2	4
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	e33ac27f-43ae-4912-8e41-626091fc5ad2	4
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	e33ac27f-43ae-4912-8e41-626091fc5ad2	4
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	e33ac27f-43ae-4912-8e41-626091fc5ad2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-7350-56	00093735056	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-7350-56)	2009-11-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole	Teva Pharmaceuticals USA, Inc.	2022-03-31	HUMAN PRESCRIPTION DRUG LABEL	25
Lansoprazole	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	4
Lansoprazole	Physicians Total Care, Inc.	2012-01-04	HUMAN PRESCRIPTION DRUG LABEL	4