Demeclocycline Hydrochloride

Product NDC: 62584-163
Requested package NDC: 62584-163-65
11-digit product format: 625840163
Labeler code: 62584
Product ID: 62584-163_e8a2c3c1-bb4e-a7fa-e053-2995a90a52f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Demeclocycline Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA065425
Marketing category: ANDA
Marketing start: 2010-12-09
Marketing end: 0000-00-00
Substance: DEMECLOCYCLINE HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Tetracycline-class Antimicrobial [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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	62584-163	62584-163-65	D	Discontinued by firm		2026-08-10

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
A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27
A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065425-001	AB
A065425-002	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	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065425-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2008-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065425-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2008-02-27	`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	A065425-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065425-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065425-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065425-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065425-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065425-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065425-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065425-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065425-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065425-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065425-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065425-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065425-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065425-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065425-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065425-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065425-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065425-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065425-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065425-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065425-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065425-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065425-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065425-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065425-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065425-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065425-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065425-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065425-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065425-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065425-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065425-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065425-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065425-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065425-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065425-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065425-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065425-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065425-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065425-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62584-163-11	EA - Each	62584-163	57da3da2-531f-447f-bd3e-a8283f93dad8	1	2012-07-24
62584-163-65	EA - Each	62584-163	5f032fc2-4621-43bf-b5b0-a114b3ccc931	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEMECLOCYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	29O079NTYT	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
DEMECLOCYCLINE	ACTIVE MOIETY	5R5W9ICI6O	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEMECLOCYCLINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Demeclocycline Hydrochloride	DEMECLOCYCLINE	Amneal Pharmaceuticals of New York LLC	539add06-e0a0-401a-b4f6-20776084aa9c	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065425 application number: ANDA065425
Demeclocycline Hydrochloride	DEMECLOCYCLINE	Amneal Pharmaceuticals LLC	4ff23e3b-e111-47fd-9776-1d89d6da049b	2024-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065425 application number: ANDA065425
Demeclocycline Hydrochloride	DEMECLOCYCLINE	American Health Packaging	e6adaf70-5ff9-4395-bff1-0f332090cb80	2024-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065425 application number: ANDA065425

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
29O079NTYT	DEMECLOCYCLINE HYDROCHLORIDE	64-73-3	DEMECLOCYCLINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62584-163-65	62584016365	50 BLISTER PACK in 1 BOX, UNIT-DOSE (62584-163-65) > 1 TABLET in 1 BLISTER PACK (62584-163-11)	50 blister pack	2010-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP FOR ORAL USE 8015901/0419 Rx only	American Health Packaging	2023-01-27	HUMAN PRESCRIPTION DRUG LABEL	7