Doxycycline

Product NDC: 55289-866
Requested package NDC: 55289-866-93
11-digit product format: 552890866
Labeler code: 55289
Product ID: 55289-866_4d536efb-27b1-2589-e063-6394a90ad3e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA065095
Marketing category: ANDA
Marketing start: 2003-07-02
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A065095-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065095-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065095-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2003-07-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065095-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065095-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065095-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065095-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065095-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065095-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065095-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065095-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065095-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065095-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065095-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065095-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065095-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065095-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065095-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065095-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065095-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065095-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065095-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065095-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065095-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065095-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065095-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065095-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065095-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065095-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065095-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065095-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065095-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065095-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065095-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065095-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065095-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065095-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065095-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065095-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065095-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065095-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065095-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065095-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxycycline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19XTS3T51U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1650143	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
c96d3986-9d92-4ec4-a319-a50aeb2f4fe7	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55289-866-01	Doxycycline	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100	32
55289-866-02	Doxycycline	2 in 1 BOTTLE, PLASTIC	TABLET, COATED	2	32
55289-866-04	Doxycycline	4 in 1 BOTTLE, PLASTIC	TABLET, COATED	4	32
55289-866-06	Doxycycline	6 in 1 BOTTLE, PLASTIC	TABLET, COATED	6	32
55289-866-07	Doxycycline	7 in 1 BOTTLE, PLASTIC	TABLET, COATED	7	32
55289-866-10	Doxycycline	10 in 1 BOTTLE, PLASTIC	TABLET, COATED	10	32
55289-866-20	Doxycycline	20 in 1 BOTTLE, PLASTIC	TABLET, COATED	20	32
55289-866-28	Doxycycline	28 in 1 BOTTLE, PLASTIC	TABLET, COATED	28	32
55289-866-30	Doxycycline	30 in 1 BOTTLE, PLASTIC	TABLET, COATED	30	32
55289-866-50	Doxycycline	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	32
55289-866-60	Doxycycline	60 in 1 BOTTLE, PLASTIC	TABLET, COATED	60	32
55289-866-71	Doxycycline	210 in 1 BOTTLE, PLASTIC	TABLET, COATED	210	32
55289-866-74	Doxycycline	400 in 1 BOTTLE, PLASTIC	TABLET, COATED	400	32
55289-866-82	Doxycycline	500 in 1 BOTTLE, PLASTIC	TABLET, COATED	500	32
55289-866-85	Doxycycline	330 in 1 BOTTLE, PLASTIC	TABLET, COATED	330	32
55289-866-86	Doxycycline	360 in 1 BOTTLE, PLASTIC	TABLET, COATED	360	32
55289-866-87	Doxycycline	300 in 1 BOTTLE, PLASTIC	TABLET, COATED	300	32
55289-866-90	Doxycycline	90 in 1 BOTTLE, PLASTIC	TABLET, COATED	90	32
55289-866-93	Doxycycline	180 in 1 BOTTLE, PLASTIC	TABLET, COATED	180	32
55289-866-95	Doxycycline	1000 in 1 BOTTLE, PLASTIC	TABLET, COATED	1000	32
55289-866-98	Doxycycline	120 in 1 BOTTLE, PLASTIC	TABLET, COATED	120	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-866-01	EA - Each	55289-866	90743e2a-3c73-4f2d-9567-5d16c7b9ebbf	1	2012-07-24
55289-866-02	EA - Each	55289-866	cf91906d-ee21-4b7f-8aa2-d70de380772c	1	2012-07-24
55289-866-04	EA - Each	55289-866	d5365061-4f32-4e76-be18-838c300a035e	1	2012-07-24
55289-866-06	EA - Each	55289-866	ceb5a2be-402f-409d-92ad-e3f7adea4ad5	1	2012-07-24
55289-866-07	EA - Each	55289-866	528be083-44f0-4d3d-9421-a24bd26c0f07	1	2016-10-06
55289-866-10	EA - Each	55289-866	b8b42050-b9ee-4136-bb0e-9adc48580960	1	2012-07-24
55289-866-14	EA - Each	55289-866	8348cbc6-a75b-420d-9291-76b9b2aaaf54	1	2012-07-24
55289-866-20	EA - Each	55289-866	c21ea079-10a7-46de-b01c-dda0ab092ef7	1	2012-07-24
55289-866-28	EA - Each	55289-866	0e46af55-ef2a-4f2a-a840-197a6fc20e4a	1	2012-07-24
55289-866-30	EA - Each	55289-866	aad12231-a0a8-4a19-b6a2-021ad9dff692	1	2012-07-24
55289-866-50	EA - Each	55289-866	6c63a6f3-2054-4ab1-822c-1ecd1f3479e6	1	2025-02-10
55289-866-60	EA - Each	55289-866	68d8e272-b7ea-4a53-aa4b-6eb08d3a9e62	1	2012-07-24
55289-866-71	EA - Each	55289-866	6c87a3a8-a536-45e0-8542-bbb0209e0a77	1	2015-01-05
55289-866-74	EA - Each	55289-866	102006d5-a933-4eab-bee5-9a7a7794d445	1	2012-07-24
55289-866-82	EA - Each	55289-866	d219cfad-cca5-4ad8-af21-f926f37fafe3	1	2025-02-10
55289-866-85	EA - Each	55289-866	d8c4cd70-a87b-449d-bee5-5be8735205c7	1	2014-08-01
55289-866-86	EA - Each	55289-866	786a2c1d-c164-46a9-b9f7-913e273d9ebe	1	2012-07-24
55289-866-87	EA - Each	55289-866	5346778f-fb1e-468f-9cbe-cb447021d438	1	2012-07-24
55289-866-90	EA - Each	55289-866	68ebcfc0-a4c9-49c7-9654-faeebdb7a914	1	2012-07-24
55289-866-93	EA - Each	55289-866	ae97f53b-9317-49fe-8c71-970551f7a979	1	2012-07-24
55289-866-95	EA - Each	55289-866	4ba23965-27da-4124-9384-81fed18cde27	1	2025-02-10
55289-866-98	EA - Each	55289-866	b896f1cb-48a0-4c7f-a4c6-a3bacf6d8253	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55289-866	DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]	31	Current NDC, Legacy NDC, 21 package rows	20250524_c96d3986-9d92-4ec4-a319-a50aeb2f4fe7.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	c96d3986-9d92-4ec4-a319-a50aeb2f4fe7	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095 ndc (package): 55289-866-93 ndc (product): 55289-866 ndc11 (package): 55289086693
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Cardinal Health 107, LLC	a34fbbc7-09dc-42d6-a075-f4ea8f170ba7	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	American Health Packaging	10988250-b267-4f10-b264-5f127cc1ae18	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	db53637e-16ac-41b0-b9d5-553471405d64	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Northwind Health Company, LLC	f7f6dc0d-cf8f-50b5-e053-6294a90a9e59	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	QPharma, Inc.	fbd0a22f-b365-c0a2-e053-6394a90a1e07	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline	DOXYCYCLINE HYCLATE	Golden State Medical Supply, Inc.	5fbef611-39db-4a8e-8f46-090c95a27042	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Major Pharmaceuticals	e7c14a8e-c713-4f03-94e8-1ec9ae077d4d	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline	DOXYCYCLINE HYCLATE	Cardinal Health 107, LLC	53deb73a-c828-46e8-994e-d84e3bf8dc98	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Hikma Pharmaceuticals USA Inc.	9b52e0a7-f024-4d8a-a59e-374946e60b44	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	6772807d-a39e-47ce-9584-a08e7f8940d2	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065095 application number: ANDA065095

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
1650143	doxycycline hyclate 100 MG Oral Tablet	PSN	c96d3986-9d92-4ec4-a319-a50aeb2f4fe7	32
1650143	doxycycline hyclate 100 MG Oral Tablet	SCD	c96d3986-9d92-4ec4-a319-a50aeb2f4fe7	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-866-93	55289086693	180 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-93)	2008-12-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXYCYCLINE HYCLATE TABLETS, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	33