PREVPAC

Product NDC: 64764-702
11-digit product format: 647640702
Labeler code: 64764
Product ID: 64764-702_bd24e0cf-b60c-49a2-9518-8c7d48861131
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lansoprazole, amoxicillin and clarithromycin
Dosage form: KIT
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA050757
Marketing category: NDA
Marketing start: 1997-12-02
Marketing end: 2021-02-28
Active strength: 0
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64764-702		D	Discontinued by firm		2026-10-05
excluded package	package	64764-702	64764-702-01	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-702-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-702-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-702-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-702-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-702-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-702-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-702-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-702-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-702-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-702-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64764-702-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64764-702-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050757-001	PREVPAC (COPACKAGED)	AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1997-12-02

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050757-001	PREVPAC	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	RLD	1997-12-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050757-001	PREVPAC	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	RLD	1997-12-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050757-001	PREVPAC	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	RLD	1997-12-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050757-001	PREVPAC	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	RLD	1997-12-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050757-001	PREVPAC	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	RLD	1997-12-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050757-001	PREVPAC	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	RLD	1997-12-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050757-001	PREVPAC	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	RLD	1997-12-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050757-001	PREVPAC	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG	CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORAL	RLD	1997-12-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050757-001	PREVPAC (COPACKAGED)	500MG;500MG;30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORAL	RLD	1997-12-02	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
502415e5-4ac7-4266-a01a-ef44aa3c028d	Product name	7	20250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0f	Product name	3	20250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5c	Product name	3	20230314
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2	Product name	7	20221114
d6b97638-59f4-48e2-8959-569628732c46	Product name	9	20210622
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64764-702-01	EA - Each	64764-702	37717f40-5e7a-496b-8657-be8ecaf37b0f	1	2012-07-24
64764-702-11	EA - Each	64764-702	a50ea81d-4aad-4768-b580-97ba5b82b878	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
amoxicillin	ACTIVE INGREDIENT	804826J2HU	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
clarithromycin	ACTIVE INGREDIENT	H1250JIK0A	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
clarithromycin	ACTIVE MOIETY	H1250JIK0A	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
D&C Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
gelatin	INACTIVE INGREDIENT	2G86QN327L	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
magnesium carbonate	INACTIVE INGREDIENT	0E53J927NA	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
methacrylic acid - ethyl acrylate copolymer (1:1) type A	INACTIVE INGREDIENT	NX76LV5T8J	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
sorbic acid	INACTIVE INGREDIENT	X045WJ989B	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
sorbitan monooleate	INACTIVE INGREDIENT	06XEA2VD56	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
sucrose	INACTIVE INGREDIENT	C151H8M554	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
talc	INACTIVE INGREDIENT	7SEV7J4R1U	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
vanillin	INACTIVE INGREDIENT	CHI530446X	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	7
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
CLARITHROMYCIN	ACTIVE INGREDIENT	H1250JIK0A	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
AMOXICILLIN	ACTIVE MOIETY	804826J2HU	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
CLARITHROMYCIN	ACTIVE MOIETY	H1250JIK0A	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
SORBITAN MONOOLEATE	INACTIVE INGREDIENT	06XEA2VD56	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2
VANILLIN	INACTIVE INGREDIENT	CHI530446X	PREVPAC (LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
757969	{4 (amoxicillin 500 MG Oral Capsule [Trimox]) / 2 (clarithromycin 500 MG Oral Tablet [Biaxin]) / 2 (lansoprazole 30 MG Delayed Release Oral Capsule [Prevacid]) } Pack [Prevpac]	BPCK	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
757968	{4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (lansoprazole 30 MG Delayed Release Oral Capsule) } Pack	GPCK	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
757968	4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (lansoprazole 30 MG Delayed Release Oral Capsule) Pack	PSN	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
308191	amoxicillin 500 MG Oral Capsule	PSN	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
205866	Biaxin Filmtab 500 MG Oral Tablet	PSN	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
197517	clarithromycin 500 MG Oral Tablet	PSN	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
206206	Prevacid 30 MG Delayed Release Oral Capsule	PSN	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
757969	Prevpac Patient Therapy Pack	PSN	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
94406	Trimox 500 MG Oral Capsule	PSN	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
94406	amoxicillin 500 MG Oral Capsule [Trimox]	SBD	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
205866	clarithromycin 500 MG Oral Tablet [Biaxin]	SBD	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
206206	lansoprazole 30 MG Delayed Release Oral Capsule [Prevacid]	SBD	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
308191	amoxicillin 500 MG Oral Capsule	SCD	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
197517	clarithromycin 500 MG Oral Tablet	SCD	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
205866	Biaxin 500 MG Oral Tablet	SY	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
206206	Prevacid 30 MG Delayed Release Oral Capsule	SY	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
757969	Prevpac Patient Therapy Pack	SY	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2
94406	Trimox 500 MG Oral Capsule	SY	7c3d8c2c-ece6-4aba-8b5a-3865402cffcf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64764-702-01	64764070201	14 BLISTER PACK in 1 BOX (64764-702-01) > 1 KIT in 1 BLISTER PACK (64764-702-11)	14 blister pack	1997-12-02	2021-02-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREVPAC	Takeda Pharmaceuticals America, Inc.	2020-06-15	HUMAN PRESCRIPTION DRUG LABEL	13
PREVPAC ® (lansoprazole 30 mg capsules, amoxicillin 500 mg capsules, USP, and clarithromycin 500 mg tablets, USP)	Physicians Total Care, Inc.	2010-03-15	HUMAN PRESCRIPTION DRUG LABEL	2