Demeclocycline Hydrochloride

Product NDC: 65162-555
11-digit product format: 651620555
Labeler code: 65162
Product ID: 65162-555_4cd13048-b500-48bc-b998-e47aafff605e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Demeclocycline
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA065425
Marketing category: ANDA
Marketing start: 2008-02-27
Substance: DEMECLOCYCLINE HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Demeclocycline Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEMECLOCYCLINE HYDROCHLORIDE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
29O079NTYT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905341	Internal RxNorm lookup
905347	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
4ff23e3b-e111-47fd-9776-1d89d6da049b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b5dbb1ae-e36f-978d-e5e0-8711031739bc	Product name	2	20150904

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-555-48	Demeclocycline Hydrochloride	48 in 1 BOTTLE	TABLET	48		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-555-48	EA - Each	65162-555	dbc248fa-2cec-4f48-9c8e-2bef3e4b8206	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 (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
DEMECLOCYCLINE	ACTIVE MOIETY	5R5W9ICI6O	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
ALGINIC ACID	INACTIVE INGREDIENT	8C3Z4148WZ	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	5
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-555	DEMECLOCYCLINE HYDROCHLORIDE (DEMECLOCYCLINE) TABLET [AMNEAL PHARMACEUTICALS LLC]	14	Current NDC, Legacy NDC, 1 package rows	20241027_4ff23e3b-e111-47fd-9776-1d89d6da049b.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 · 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 ndc (product): 65162-555
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
5R5W9ICI6O	DEMECLOCYCLINE	127-33-3	Demeclocycline

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905341	demeclocycline HCl 150 MG Oral Tablet	PSN	4ff23e3b-e111-47fd-9776-1d89d6da049b	14
905347	demeclocycline HCl 300 MG Oral Tablet	PSN	4ff23e3b-e111-47fd-9776-1d89d6da049b	14
905341	demeclocycline hydrochloride 150 MG Oral Tablet	SCD	4ff23e3b-e111-47fd-9776-1d89d6da049b	14
905347	demeclocycline hydrochloride 300 MG Oral Tablet	SCD	4ff23e3b-e111-47fd-9776-1d89d6da049b	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-555-48	65162055548	48 TABLET in 1 BOTTLE (65162-555-48)	48 tablet	2008-02-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Demeclocycline Hydrochloride	Amneal Pharmaceuticals LLC	2024-10-24	HUMAN PRESCRIPTION DRUG LABEL	14
DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP FOR ORAL USE 8015901/0419 Rx only	American Health Packaging	2023-01-27	HUMAN PRESCRIPTION DRUG LABEL	7
Demeclocycline Hydrochloride	Major Pharmaceuticals	2019-11-12	HUMAN PRESCRIPTION DRUG LABEL	2
Demeclocycline Hydrochloride Tablets, USP	AvKARE, Inc.	2019-08-06	HUMAN PRESCRIPTION DRUG LABEL	4