NDC 42806-646 - DOXYCYCLINE HYCLATE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 42806-646
Package NDCs from labels: 42806-646-60, 42806-646-01, 42806-646-05
Manufacturer: EPIC PHARMA, LLC | Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe
Effective date: 2023-09-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
DOXYCYCLINE HYCLATE - EPIC PHARMA, LLC \| Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe	EPIC PHARMA, LLC \| Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe	2023-09-18	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42806-646-01	2025-07-29	C162847	48780-1	3b156c62-3055-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use DOXYCYCLINE HYCLATE TABLETS safely and effectively. See full prescribing information for DOXYCYCLINE HYCLATE TABLETS. Initial U.S. Approval: 1967
42806-646-05	2025-07-29	C162847	48780-1	3b156c62-3055-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use DOXYCYCLINE HYCLATE TABLETS safely and effectively. See full prescribing information for DOXYCYCLINE HYCLATE TABLETS. Initial U.S. Approval: 1967
42806-646-60	2025-07-29	C162847	48780-1	3b156c62-3055-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use DOXYCYCLINE HYCLATE TABLETS safely and effectively. See full prescribing information for DOXYCYCLINE HYCLATE TABLETS. Initial U.S. Approval: 1967

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42806-646-01	DOXYCYCLINE HYCLATE	100 in 1 BOTTLE	TABLET, COATED	100		1
42806-646-05	DOXYCYCLINE HYCLATE	500 in 1 BOTTLE	TABLET, COATED	500		1
42806-646-60	DOXYCYCLINE HYCLATE	60 in 1 BOTTLE	TABLET, COATED	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-646	DOXYCYCLINE HYCLATE (DOXYCLYCLINE HYCLATE) TABLET, COATED [EPIC PHARMA, LLC]	1	3 package rows	20230919_2cffb084-2b25-4e1b-846b-8681de7ea666.zip