Omeclamox-Pak

Product NDC: 66220-422
11-digit product format: 662200422
Labeler code: 66220
Product ID: 66220-422_13c419e8-64ba-41d9-ae34-17ce8596bcd7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole, clarithromycin, amoxicillin
Dosage form: KIT
Labeler: Cumberland Pharmaceuticals Inc.
Application: NDA050824
Marketing category: NDA
Marketing start: 2012-04-27
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66220-422		I	Inactivated by FDA	2026-08-11
excluded package	package	66220-422	66220-422-01	I	Inactivated by FDA	2026-08-11
excluded package	package	66220-422	66220-422-02	I	Inactivated by FDA	2026-08-11

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66220-422-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66220-422-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66220-422-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66220-422-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66220-422-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66220-422-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66220-422-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66220-422-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66220-422-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66220-422-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66220-422-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66220-422-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66220-422-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66220-422-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66220-422-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66220-422-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66220-422-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66220-422-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050824-001	OMECLAMOX-PAK	AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL		RLD	2011-02-08

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050824-001	OMECLAMOX-PAK	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050824-001	OMECLAMOX-PAK	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050824-001	OMECLAMOX-PAK	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050824-001	OMECLAMOX-PAK	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050824-001	OMECLAMOX-PAK	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050824-001	OMECLAMOX-PAK	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050824-001	OMECLAMOX-PAK	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050824-001	OMECLAMOX-PAK	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050824-001	OMECLAMOX-PAK	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2011-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2011-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2011-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2011-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2011-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2011-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2011-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2011-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050824-001	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE / ORAL	RLD	2011-02-08	`cb3db0bc1861…`

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
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
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
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66220-422-01	2025-01-30	C162847	48780-1	2cef2736-610e-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use OMECLAMOX ® -PAK safely and effectively. See full prescribing information for OMECLAMOX-PAK. OMECLAMOX-PAK (omeprazole delayed-release capsules; clarithromycin tablets, amoxicillin capsules) co-packaged for oral use Initial U.S. Approval: 2011
66220-422-02	2025-01-30	C162847	48780-1	2cef2736-610e-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use OMECLAMOX ® -PAK safely and effectively. See full prescribing information for OMECLAMOX-PAK. OMECLAMOX-PAK (omeprazole delayed-release capsules; clarithromycin tablets, amoxicillin capsules) co-packaged for oral use Initial U.S. Approval: 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66220-422-01	Omeclamox-Pak	1 in 1 BLISTER PACK	KIT	1	10
66220-422-02	Omeclamox-Pak	1 in 1 BLISTER PACK	KIT	1	10
66220-422-02	Omeclamox-Pak	10 in 1 CARTON	KIT	10	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66220-422-01	EA - Each	66220-422	b833ea72-dedb-44ac-a227-5d529600bc0d	1	2016-12-07
66220-422-02	EA - Each	66220-422	9e291c34-dc02-4432-9a32-a9125d589b5a	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66220-422	OMECLAMOX-PAK (OMEPRAZOLE, CLARITHROMYCIN, AMOXICILLIN) KIT [CUMBERLAND PHARMACEUTICALS INC.]	10	Legacy NDC, 3 package rows	20230819_9e52c29a-fdbe-4a4d-b280-d700eba5b94f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1291987	{4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (omeprazole 20 MG Delayed Release Oral Capsule) } Pack [Omeclamox]	BPCK	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
1291986	{4 (amoxicillin 500 MG Oral Capsule) / 2 (clarithromycin 500 MG Oral Tablet) / 2 (omeprazole 20 MG Delayed Release Oral Capsule) } Pack	GPCK	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
308191	amoxicillin 500 MG Oral Capsule	PSN	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
1291986	amoxicillin 500 MG Oral Capsule (4) / clarithromycin 500 MG Oral Tablet (2) / omeprazole 20 MG Delayed Release Oral Capsule (2) Pack	PSN	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
197517	clarithromycin 500 MG Oral Tablet	PSN	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
1291987	Omeclamox-Pak	PSN	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
308191	amoxicillin 500 MG Oral Capsule	SCD	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
197517	clarithromycin 500 MG Oral Tablet	SCD	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
1291987	Omeclamox-Pak	SY	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	9e52c29a-fdbe-4a4d-b280-d700eba5b94f	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66220-422-01	66220042201	1 KIT in 1 BLISTER PACK (66220-422-01)	1 kit	2012-04-27	0000-00-00	No	No	Current
66220-422-02	66220042202	10 BLISTER PACK in 1 CARTON (66220-422-02) > 1 KIT in 1 BLISTER PACK	10 blister pack	2012-04-27	0000-00-00	No	No	Current