Doxycycline Hyclate

Product NDC: 71205-697
11-digit product format: 712050697
Labeler code: 71205
Product ID: 71205-697_dd7672c9-b10f-4ea1-9000-ef3e3faa10db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA062505
Marketing category: ANDA
Marketing start: 1984-09-11
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 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 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
A062505-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		1984-09-11
A062505-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB		2021-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062505-001	AB
A062505-002	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 2 · 74 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	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062505-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	TABLET / ORAL	AB	2021-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062505-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	1984-09-11	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A062505-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062505-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062505-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062505-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062505-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062505-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062505-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062505-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062505-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062505-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062505-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062505-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062505-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062505-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062505-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062505-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062505-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062505-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062505-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062505-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062505-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062505-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062505-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062505-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062505-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062505-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062505-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062505-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062505-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062505-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062505-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062505-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062505-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062505-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062505-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062505-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062505-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062505-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062505-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062505-001	AB	1	`87673890dc5c…`

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	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
dd7672c9-b10f-4ea1-9000-ef3e3faa10db	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
71205-697-10	Doxycycline Hyclate	10 in 1 BOTTLE	TABLET, FILM COATED	10	1
71205-697-14	Doxycycline Hyclate	14 in 1 BOTTLE	TABLET, FILM COATED	14	1
71205-697-20	Doxycycline Hyclate	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
71205-697-30	Doxycycline Hyclate	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
71205-697-60	Doxycycline Hyclate	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
71205-697-90	Doxycycline Hyclate	90 in 1 BOTTLE	TABLET, FILM COATED	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-697-20	EA - Each	71205-697	75327d96-7d54-4120-9ff9-7e6097e6ee0a	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-697	DOXYCYCLINE HYCLATE TABLET, FILM COATED [PROFICIENT RX LP]	1	Current NDC, Legacy NDC, 6 package rows	20220919_dd7672c9-b10f-4ea1-9000-ef3e3faa10db.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	b70a3a12-76a2-4558-bf2c-eaa38a9ba0a0	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062505 application number: ANDA062505
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Golden State Medical Supply, Inc.	98bf51e7-01f8-e3f7-e053-2995a90a42f0	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062505 application number: ANDA062505
doxycycline	DOXYCYCLINE	Chartwell Governmental & Specialty RX, LLC	b8486639-7eb9-4610-9cd4-0e922045d592	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062505 application number: ANDA062505
doxycycline	DOXYCYCLINE	Chartwell RX LLC	3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062505 application number: ANDA062505
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Redpharm Drug, Inc.	09d19663-a8b9-0c3f-e063-6394a90aa446	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062505 application number: ANDA062505
DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	direct rx	b56dffde-1334-f5a0-e053-2a95a90a717c	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062505 application number: ANDA062505
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	a707c9e3-00eb-e832-e053-2a95a90a5f58	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062505 application number: ANDA062505
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	A-S Medication Solutions	a84d7562-08bf-417f-a599-ba0d17c55232	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062505 application number: ANDA062505
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Proficient Rx LP	dd7672c9-b10f-4ea1-9000-ef3e3faa10db	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062505 application number: ANDA062505 ndc (product): 71205-697

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	dd7672c9-b10f-4ea1-9000-ef3e3faa10db	1
1650143	doxycycline hyclate 100 MG Oral Tablet	SCD	dd7672c9-b10f-4ea1-9000-ef3e3faa10db	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-697-10	71205069710	10 TABLET, FILM COATED in 1 BOTTLE (71205-697-10)	2022-09-14	0000-00-00	No	No	Current
71205-697-14	71205069714	14 TABLET, FILM COATED in 1 BOTTLE (71205-697-14)	2022-09-14	0000-00-00	No	No	Current
71205-697-20	71205069720	20 TABLET, FILM COATED in 1 BOTTLE (71205-697-20)	2022-09-14	0000-00-00	No	No	Current
71205-697-30	71205069730	30 TABLET, FILM COATED in 1 BOTTLE (71205-697-30)	2022-09-14	0000-00-00	No	No	Current
71205-697-60	71205069760	60 TABLET, FILM COATED in 1 BOTTLE (71205-697-60)	2022-09-14	0000-00-00	No	No	Current
71205-697-90	71205069790	90 TABLET, FILM COATED in 1 BOTTLE (71205-697-90)	2022-09-14	0000-00-00	No	No	Current