Doxycycline Hyclate

Product NDC: 0591-4550
11-digit product format: 005914550
Labeler code: 0591
Product ID: 0591-4550_7a5f0596-e96f-442b-8d67-186c8a81145e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA090134
Marketing category: ANDA
Marketing start: 2019-08-14
Marketing end: 2027-06-30
Substance: DOXYCYCLINE HYCLATE
Active strength: 50 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090134-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14
A090134-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14
A090134-003	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22
A090134-004	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090134-001	AB
A090134-002	AB
A090134-003	AB
A090134-004	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 5 · 164 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	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090134-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090134-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090134-003	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090134-004	DOXYCYCLINE HYCLATE	EQ 200MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2018-05-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A090134-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090134-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090134-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090134-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090134-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090134-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090134-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090134-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090134-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090134-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090134-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090134-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090134-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090134-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090134-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090134-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090134-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090134-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090134-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090134-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090134-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090134-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090134-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090134-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090134-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxycycline Hyclate

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	50 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1423080	Internal RxNorm lookup
1653433	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
c2b08332-3256-4658-965a-ede3d973a388	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	Strength	SPL version
0591-4550-22	Doxycycline Hyclate	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-4550-22	EA - Each	0591-4550	74fcfc93-14fa-4d52-9039-470eb2f37160	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-4550	DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20250508_c2b08332-3256-4658-965a-ede3d973a388.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Actavis Pharma, Inc.	c2b08332-3256-4658-965a-ede3d973a388	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090134 application number: ANDA090134 ndc (product): 0591-4550

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
1423080	doxycycline hyclate 200 MG Delayed Release Oral Tablet	PSN	c2b08332-3256-4658-965a-ede3d973a388	8
1653433	doxycycline hyclate 50 MG Delayed Release Oral Tablet	PSN	c2b08332-3256-4658-965a-ede3d973a388	8
1423080	doxycycline hyclate 200 MG Delayed Release Oral Tablet	SCD	c2b08332-3256-4658-965a-ede3d973a388	8
1653433	doxycycline hyclate 50 MG Delayed Release Oral Tablet	SCD	c2b08332-3256-4658-965a-ede3d973a388	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-4550-22	00591455022	120 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-4550-22)	2019-08-14	0000-00-00	No	No	Current