Doxycycline Hyclate

Product NDC: 72789-309
Requested package NDC: 72789-309-60
11-digit product format: 727890309
Labeler code: 72789
Product ID: 72789-309_38052f8d-1d68-b250-e063-6394a90a8b48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA065134
Marketing category: ANDA
Marketing start: 2005-05-13
Substance: DOXYCYCLINE HYCLATE
Active strength: 20 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065134-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB		2005-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065134-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065134-001	DOXYCYCLINE HYCLATE	EQ 20MG BASE	TABLET / ORAL	AB	2005-05-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065134-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065134-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065134-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065134-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065134-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065134-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065134-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065134-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065134-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065134-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065134-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065134-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065134-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065134-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065134-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065134-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065134-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065134-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065134-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065134-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065134-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065134-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065134-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065134-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065134-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065134-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065134-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065134-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065134-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065134-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065134-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065134-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065134-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065134-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065134-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065134-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065134-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065134-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065134-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065134-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Doxycycline Hyclate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYCYCLINE HYCLATE	20 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
283535	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
294c6fc3-e7ca-46ea-b062-a27dd7b0bc97	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
72789-309-01	Doxycycline Hyclate	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	15
72789-309-60	Doxycycline Hyclate	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	15
72789-309-93	Doxycycline Hyclate	180 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	180	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-309-01	EA - Each	72789-309	d5d9a2d6-2780-4f37-b154-31c81dd07753	1	2023-04-07
72789-309-60	EA - Each	72789-309	728a912c-0f31-41ba-b25d-9a7fe0aaa15c	1	2023-04-07
72789-309-93	EA - Each	72789-309	ab7eeed4-77e7-4d67-a7b3-396df94da20e	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-309	DOXYCYCLINE HYCLATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	14	Current NDC, 3 package rows	20250221_294c6fc3-e7ca-46ea-b062-a27dd7b0bc97.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 · 2 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.	294c6fc3-e7ca-46ea-b062-a27dd7b0bc97	2025-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065134 application number: ANDA065134 ndc (package): 72789-309-60 ndc (product): 72789-309 ndc11 (package): 72789030960
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Sun Pharmaceutical Industries, Inc.	bff3f426-44fc-4dbf-96df-df44011103e8	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065134 application number: ANDA065134

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
283535	doxycycline hyclate 20 MG Oral Tablet	PSN	294c6fc3-e7ca-46ea-b062-a27dd7b0bc97	15
283535	doxycycline hyclate 20 MG Oral Tablet	SCD	294c6fc3-e7ca-46ea-b062-a27dd7b0bc97	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72789-309-60	72789030960	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-309-60)	2023-03-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXYCYCLINE HYCLATE TABLETS USP	PD-Rx Pharmaceuticals, Inc.	2025-06-20	HUMAN PRESCRIPTION DRUG LABEL	15