Doxycycline Hyclate

Product NDC: 42254-426
11-digit product format: 422540426
Labeler code: 42254
Product ID: 42254-426_87fce959-ba71-46b8-911d-2004658196ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline Hyclate
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA062396
Marketing category: ANDA
Marketing start: 1984-11-07
Marketing end: 0000-00-00
Substance: DOXYCYCLINE HYCLATE
Active strength: 50 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42254-426		I	Inactivated by FDA		2026-08-03
excluded package	package	42254-426	42254-426-20	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-426-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-426-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-426-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-426-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-426-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-426-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-426-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-426-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-426-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-426-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-426-20	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-426-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-426-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-426-20	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-426-20	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-426-20	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-426-20	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-426-20	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-426-20	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-426-20	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-426-20	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-426-20	`110d247fa046…`	`a55b01930146…`

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
A062396-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07
A062396-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062396-001	AB
A062396-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RS	1984-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062396-001	DOXYCYCLINE HYCLATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1984-05-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062396-002	DOXYCYCLINE HYCLATE	EQ 50MG BASE	CAPSULE / ORAL	AB		1984-11-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A062396-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062396-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062396-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062396-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062396-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062396-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062396-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062396-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062396-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062396-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062396-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062396-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062396-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062396-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062396-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062396-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062396-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062396-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062396-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062396-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062396-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062396-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062396-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062396-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062396-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062396-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062396-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062396-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062396-002	AB	1	`782e0a99824c…`

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
42254-426-20	2019-09-24	C162847	48780-1	9350213a-3c2f-c013-e053-90daa90a1393	DOXYCYCLINE HYCLATE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-426-20	Doxycycline Hyclate	20 in 1 BOTTLE	CAPSULE	20		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYCYCLINE HYCLATE	ACTIVE INGREDIENT	19XTS3T51U	DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-426	DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20120420_87fce959-ba71-46b8-911d-2004658196ce.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxycyclate Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	4dc319c1-b7ef-40e4-9e66-fb24cfdefea8	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Unit Dose Solutions, Inc.	548d4218-2feb-8716-e063-6394a90afbe3	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	e24a3292-0d4f-4692-8cf7-a82bd19e5932	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	PD-Rx Pharmaceuticals, Inc.	5f523294-e62b-4da5-8799-047d4bed966f	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	52ba329a-8cb3-cf30-e063-6394a90aa0dc	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	REMEDYREPACK INC.	3a85933f-bd73-4ad7-968d-c90cb7c7a60c	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Northwind Health Company, LLC	f309ccbb-b68a-3190-e053-2995a90a0ad4	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Major Pharmaceuticals	c4aae81f-0219-450f-aa60-953964f74172	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	8c525e4e-6e1b-4579-e053-2a95a90a43da	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	American Health Packaging	e98d11b0-535f-4e57-9639-6358835c04bc	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Hikma Pharmaceuticals USA Inc.	4ec4c8ca-ce83-4948-8626-21eb82ae5c19	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Coupler LLC	325d5331-d48e-1bc4-e063-6394a90a65b9	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline	DOXYCYCLINE	Direct_Rx	8c273efa-62ec-16b2-e053-2995a90ac41d	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	Bryant Ranch Prepack	214e5a5c-7f3e-478b-93d3-1713de9e7672	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396
Doxycycline Hyclate	DOXYCYCLINE HYCLATE	NuCare Pharmaceuticals,Inc.	88012cf8-509b-84cf-e053-2a95a90af3bc	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062396 application number: ANDA062396

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
1649405	doxycycline hyclate 50 MG Oral Capsule	PSN	87fce959-ba71-46b8-911d-2004658196ce	1
1649405	doxycycline hyclate 50 MG Oral Capsule	SCD	87fce959-ba71-46b8-911d-2004658196ce	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-426-20	42254042620	20 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOXYCYCLINE HYCLATE CAPSULES, USP	Rebel Distributors Corp	2012-02-09	HUMAN PRESCRIPTION DRUG LABEL	1