Doxycycline Hyclate

Product NDC: 69238-1501
11-digit product format: 692381501
Labeler code: 69238
Product ID: 69238-1501_e4ab01be-7166-4895-b629-5f7f2a9fdce9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxycycline
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA209372
Marketing category: ANDA
Marketing start: 2017-10-09
Marketing end: 0000-00-00
Substance: DOXYCYCLINE
Active strength: 150 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	69238-1501		D	Discontinued by firm		2026-10-05
excluded package	package	69238-1501	69238-1501-6	D	Discontinued by firm		2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	69238-1501		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69238-1501	69238-1501-6	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A209372-001	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL			2017-10-06
A209372-002	DOXYCYCLINE HYCLATE	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL			2017-10-06

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 · 86 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
2026-09-14 22:38:34	2026-08	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL		2017-10-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL		2017-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209372-001	DOXYCYCLINE HYCLATE	EQ 75MG BASE	TABLET / ORAL	AB	2017-10-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209372-002	DOXYCYCLINE HYCLATE	EQ 150MG BASE	TABLET / ORAL	AB	2017-10-06	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A209372-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209372-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209372-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209372-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209372-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209372-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209372-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209372-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209372-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209372-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209372-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A209372-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209372-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209372-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209372-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209372-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1501-6	EA - Each	69238-1501	3394c4bd-a8fd-46f1-896c-5baa5755d1be	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1501	DOXYCYCLINE HYCLATE (DOXYCYCLINE) TABLET [AMNEAL PHARMACEUTICALS NY LLC]	7	Legacy NDC	20250516_b9fbbe52-dd65-4ee7-a797-a2c05fc1d5c8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N12000U13O	DOXYCYCLINE	17086-28-1	DOXYCYCLINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1501-6	69238150106	60 TABLET in 1 BOTTLE (69238-1501-6)	60 tablet	2017-10-09	0000-00-00	No	No	Current