Doxycycline Hyclate

Product NDC: 45865-444
11-digit product format: 458650444
Labeler code: 45865
Product ID: 45865-444_9ab23cb0-303b-f6f9-e053-2a95a90a7147
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: CAPSULE
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA062676
Marketing category: ANDA
Marketing start: 1986-07-10
Marketing end: 0000-00-00
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45865-444		I	Inactivated by FDA		2026-08-03
excluded package	package	45865-444	45865-444-14	I	Inactivated by FDA		2026-08-03

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 · 18 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	45865-444-14	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	45865-444-14	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	45865-444-14	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	45865-444-14	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	45865-444-14	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	45865-444-14	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	45865-444-14	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	45865-444-14	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	45865-444-14	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062676-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1986-07-10
A062676-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1986-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062676-001	AB
A062676-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062676-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1986-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062676-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB	1986-07-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062676-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062676-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062676-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062676-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062676-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062676-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062676-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062676-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062676-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062676-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062676-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062676-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062676-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062676-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062676-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062676-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062676-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062676-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062676-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062676-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062676-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062676-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062676-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062676-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062676-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062676-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062676-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062676-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062676-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b4321c75-2e87-4d90-9726-9a28fb2293a3	Product name	3	20260112
5e99724e-0654-4aec-b7a2-0b9b10e312ee	Product name	3	20250227
d2d36660-68ce-7e7d-0630-ec4b0d859fad	Product name	6	20220921
a239f4dd-cf93-4660-b190-f97d000f249f	Product name	7	20210607
a9d03566-caeb-4466-8021-74599b048880	Product name	3	20210604
12750814-20f7-4f35-b5fa-dbc8811ba858	Product name	9	20201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5ade	Product name	1	20200706
7b4b06ac-8c50-45f0-9556-293ea558a294	Product name	1	20180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84	Product name	5	20171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371	Product name	2	20171115
58b1278c-6dce-49b6-a05e-ea16f389acba	Product name	1	20160620

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-444-14	2025-01-30	C162847	48780-1	2cef2736-690d-d83d-e063-dadaa90ab31f	DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-444-14	Doxycycline Hyclate	14 in 1 BOTTLE, PLASTIC	CAPSULE	14		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-444	DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20191228_1dc3070b-c6ee-4dc0-e054-00144ff8d46c.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	0994d23a-f9e4-4c33-ba44-a1f4ae4a312c	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	b988f851-cc06-4570-9706-cf65d370bd8e	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	35aa295e-ff1b-453b-8eeb-65bbeda3baa5	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	6e3d0691-c071-441c-9b00-22a380305066	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	214a9cfe-a522-4022-81d4-e59f447401fe	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	DIRECT RX	9798c4de-8af7-41c4-acc2-1e9775194297	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	AvPAK	53ff9f7e-0db0-c841-d334-4cf31f658828	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	ecab47ea-d7b9-515d-e053-2995a90adc46	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Advanced Rx Pharmacy of Tennessee, LLC	f5ed9293-15f8-ecfa-e053-2a95a90ab6a4	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Quality Care Products, LLC	2a3b79e8-f14c-4b44-9d3e-3c92a82269bd	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	0fdc3d87-8819-4c2c-e063-6394a90a687b	2024-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	86c1f165-af79-4f01-ab61-3bdbce24cd0d	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062676 application number: ANDA062676

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1649988	doxycycline hyclate 100 MG Oral Capsule	PSN	1dc3070b-c6ee-4dc0-e054-00144ff8d46c	2
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	1dc3070b-c6ee-4dc0-e054-00144ff8d46c	2
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	1dc3070b-c6ee-4dc0-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-444-14	45865044414	14 CAPSULE in 1 BOTTLE, PLASTIC (45865-444-14)	14 capsule	2015-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXYCYCLINE HYCLATE CAPSULES USP 50 mg and 100 mg DOXYCYCLINE HYCLATE TABLETS USP 100 mg	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2