Doxycycline Hyclate

Product NDC: 69434-016
Requested package NDC: 69434-016-06
11-digit product format: 694340016
Labeler code: 69434
Product ID: 69434-016_274d4625-6900-4533-9918-1d8ad9c7a8d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: CAPSULE
Route: ORAL
Labeler: Zhejiang Yongtai Pharmaceutical Co., Ltd
Application: ANDA212610
Marketing category: ANDA
Marketing start: 2026-02-01
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

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A212610-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL			2020-03-31
A212610-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL			2020-03-31

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212610-001	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	2020-03-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212610-002	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	2020-03-31	`bb7c543d1eb4…`

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: 2027-12-31

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
1649405	Internal RxNorm lookup
1649988	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
ccf9708a-ed3b-4786-b3a6-e96125b2f9d5	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69434-016-03	2023-01-30	C162847	48780-1	f386c64a-193a-0266-e053-dadaa90a7c1a	Doxycycline Hyclate Capsules， USP
69434-016-06	2023-01-30	C162847	48780-1	f386c64a-193a-0266-e053-dadaa90a7c1a	Doxycycline Hyclate Capsules， USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69434-016-03	Doxycycline Hyclate	500 in 1 BOTTLE	CAPSULE	500		8
69434-016-06	Doxycycline Hyclate	50 in 1 BOTTLE	CAPSULE	50		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69434-016	DOXYCYCLINE HYCLATE CAPSULE [ZHEJIANG YONGTAI PHARMACEUTICAL CO., LTD]	7	Current NDC, Legacy NDC, 2 package rows	20210908_ccf9708a-ed3b-4786-b3a6-e96125b2f9d5.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	Zhejiang Yongtai Pharmaceutical Co., Ltd	ccf9708a-ed3b-4786-b3a6-e96125b2f9d5	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212610 application number: ANDA212610 ndc (package): 69434-016-06 ndc (product): 69434-016 ndc11 (package): 69434001606

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	ccf9708a-ed3b-4786-b3a6-e96125b2f9d5	8
1649405	doxycycline hyclate 50 MG Oral Capsule	PSN	ccf9708a-ed3b-4786-b3a6-e96125b2f9d5	8
1649988	doxycycline hyclate 100 MG Oral Capsule	SCD	ccf9708a-ed3b-4786-b3a6-e96125b2f9d5	8
1649405	doxycycline hyclate 50 MG Oral Capsule	SCD	ccf9708a-ed3b-4786-b3a6-e96125b2f9d5	8
1649988	doxycycline (as doxycycline hyclate) 100 MG Oral Capsule	SY	ccf9708a-ed3b-4786-b3a6-e96125b2f9d5	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69434-016-06	69434001606	50 CAPSULE in 1 BOTTLE (69434-016-06)	50 capsule	2026-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate Capsules， USP	Zhejiang Yongtai Pharmaceutical Co., Ltd \| Zhejiang Yongtai Pharmaceutical Co., Ltd.	2026-01-22	HUMAN PRESCRIPTION DRUG LABEL	8