DOXYCYCLINE HYCLATE

Product NDC: 61919-667
Requested package NDC: 61919-667-20
11-digit product format: 619190667
Labeler code: 61919
Product ID: 61919-667_94e15996-1873-0961-e053-2995a90a042f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXYCYCLINE HYCLATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA062505
Marketing category: ANDA
Marketing start: 2019-09-10
Marketing end: 0000-00-00
Substance: DOXYCYCLINE HYCLATE
Active strength: 100 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-667	61919-667-20	D	Discontinued by firm		2026-08-03

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 · 12 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…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-667-14	EA - Each	61919-667	0e64f733-b632-499c-8a47-44e752bfa611	1	2019-04-11
61919-667-20	EA - Each	61919-667	c070d6f3-2dc0-4233-ae75-d091f50ad21e	1	2019-10-07

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19XTS3T51U	DOXYCYCLINE HYCLATE	24390-14-5	DOXYCYCLINE HYCLATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-667-20	61919066720	20 TABLET, FILM COATED in 1 BOTTLE (61919-667-20)	2019-09-10	0000-00-00	No	No	Current