Doxycycline Hyclate

Product NDC: 67296-1431
Requested package NDC: 67296-1431-2
11-digit product format: 672961431
Labeler code: 67296
Product ID: 67296-1431_490df0fd-95eb-b265-e063-6294a90a8b45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA207773
Marketing category: ANDA
Marketing start: 2019-03-14
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

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 · 4 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
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 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
A207773-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB		2017-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207773-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207773-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-10-30	`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	A207773-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207773-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207773-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207773-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207773-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207773-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207773-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207773-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207773-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207773-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207773-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207773-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207773-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207773-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207773-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207773-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207773-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207773-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207773-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207773-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207773-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207773-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207773-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207773-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207773-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207773-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207773-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207773-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207773-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207773-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207773-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207773-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207773-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207773-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207773-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207773-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207773-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207773-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207773-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207773-001	AB	1	`cb3db0bc1861…`

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	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
bdacaaa7-b46e-ee0c-e053-2a95a90aea3c	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
67296-1431-2	2024-08-07	C162847	48780-1	f386c649-fe15-0266-e053-dadaa90a7c1a	Doxycycline Hyclate 100mg Tab
67296-1431-2	2023-01-30	C162847	48780-1	f386c649-fe15-0266-e053-dadaa90a7c1a	Doxycycline Hyclate 100mg Tab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1431-1	Doxycycline Hyclate	14 in 1 BOTTLE	TABLET	14		3
67296-1431-2	Doxycycline Hyclate	20 in 1 BOTTLE	TABLET	20		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1431	DOXYCYCLINE HYCLATE TABLET [REDPHARM DRUG, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20240808_bdacaaa7-b46e-ee0c-e053-2a95a90aea3c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	RedPharm Drug, Inc.	bdacaaa7-b46e-ee0c-e053-2a95a90aea3c	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773 ndc (package): 67296-1431-2 ndc (product): 67296-1431 ndc11 (package): 67296143102
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Viona Pharmaceuticals Inc	763997f0-b35c-43cb-a792-3e0bae589536	2025-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	5b4390ed-a0ec-4ef8-864c-8a33a83653f9	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NCS HealthCare of KY, LLC dba Vangard Labs	104cac0f-7c99-4faf-ba08-0159ed767a3e	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207773 application number: ANDA207773
Doxycycline hyclate	DOXYCYCLINE HYCLATE	Zydus Lifesciences Limited	68b3aba5-f1e4-4cdf-b244-0302aa8595fe	2024-08-16		Exact identifier application applno (ANDA): 207773 application number: ANDA207773

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	bdacaaa7-b46e-ee0c-e053-2a95a90aea3c	3
1650143	doxycycline hyclate 100 MG Oral Tablet	SCD	bdacaaa7-b46e-ee0c-e053-2a95a90aea3c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1431-2	67296143102	20 TABLET in 1 BOTTLE (67296-1431-2)	20 tablet	2021-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxycycline Hyclate 100mg Tab	RedPharm Drug, Inc. \| RedPharm Drug	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	3