Arestin

Product NDC: 65976-100
11-digit product format: 659760100
Labeler code: 65976
Product ID: 65976-100_668385ee-9443-4d20-b0ea-655c2526ca96
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline Hydrochloride
Dosage form: POWDER
Route: ORAL
Labeler: OraPharma, Inc.
Application: NDA050781
Marketing category: NDA
Marketing start: 2011-03-21
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Decreased Prothrombin Activity [PE], Tetracycline-class Drug [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050781-001	ARESTIN	MINOCYCLINE HYDROCHLORIDE	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL		RLD, RS	2001-02-16

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050781-001	ARESTIN	EQ 1MG BASE	POWDER, EXTENDED RELEASE / DENTAL	RLD, RS	2001-02-16	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050781-001	6682348	2022-03-29	Drug product	2012-05-24	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050781-001	7699609	2022-03-29	Drug product	2015-03-26	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINOCYCLINE HYDROCHLORIDE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0020414E5U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351121	Internal RxNorm lookup
351974	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
8515df41-1936-4f3b-86ba-d2bb2a8441fb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7	Product name	1	20250623
9e423e97-a6d9-7bb0-0dcb-343af7c0ff92	Product name	2	20230322
472a6924-c7ed-850b-32ce-a510e887fbf9	Product name	4	20230207
f1239550-2d2e-44c3-aec7-14fd9b4ab55d	Product name	1	20201103
7a57513a-a145-4b95-9165-1e0ef21d6017	Product name	1	20200326
70555e58-6951-4421-9354-f80c6ce0d92c	Product name	7	20200204
23de08d7-aa4e-ec8b-ce6d-2124a855e4ef	Product name	5	20180605
76736e48-254d-4a39-993d-206efbdaad1d	Product name	1	20170717
0c498039-5512-d9d7-e6b6-833de47219ff	Product name	2	20151106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65976-100-01	Arestin	1 in 1 POUCH	POWDER	1	21
65976-100-12	Arestin	1 in 1 BOX	POWDER	1	21
65976-100-12	Arestin	1 in 1 POUCH	POWDER	1	21
65976-100-24	Arestin	1 in 1 POUCH	POWDER	1	21
65976-100-24	Arestin	2 in 1 BOX	POWDER	2	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65976-100-01	EA - Each	65976-100	d9c98f75-a79b-448c-a2cc-506ae7b6abb9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Minocycline Hydrochloride	ACTIVE INGREDIENT	0020414E5U	ARESTIN (MINOCYCLINE HYDROCHLORIDE) POWDER [ORAPHARMA, INC.]	7
Minocycline	ACTIVE MOIETY	FYY3R43WGO	ARESTIN (MINOCYCLINE HYDROCHLORIDE) POWDER [ORAPHARMA, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65976-100	ARESTIN (MINOCYCLINE HYDROCHLORIDE) POWDER [ORAPHARMA, INC.]	21	Current NDC, Legacy NDC, 5 package rows	20240816_8515df41-1936-4f3b-86ba-d2bb2a8441fb.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arestin	MINOCYCLINE HYDROCHLORIDE	OraPharma, Inc.	8515df41-1936-4f3b-86ba-d2bb2a8441fb	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050781 application number: NDA050781 ndc (product): 65976-100

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0020414E5U	MINOCYCLINE HYDROCHLORIDE	13614-98-7	MINOCYCLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351974	Arestin 1 MG Oral Powder	PSN	8515df41-1936-4f3b-86ba-d2bb2a8441fb	21
351121	minocycline HCl 1 MG Oral Powder	PSN	8515df41-1936-4f3b-86ba-d2bb2a8441fb	21
351974	minocycline 1 MG Oral Powder [Arestin]	SBD	8515df41-1936-4f3b-86ba-d2bb2a8441fb	21
351121	minocycline 1 MG Oral Powder	SCD	8515df41-1936-4f3b-86ba-d2bb2a8441fb	21
351974	Arestin (minocycline hydrochloride) 1 MG Oral Powder	SY	8515df41-1936-4f3b-86ba-d2bb2a8441fb	21
351974	Arestin 1 MG Oral Powder	SY	8515df41-1936-4f3b-86ba-d2bb2a8441fb	21
351121	minocycline 1 MG (as minocycline hydrochloride) Oral Powder	SY	8515df41-1936-4f3b-86ba-d2bb2a8441fb	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65976-100-01	65976010001	1 POWDER in 1 POUCH (65976-100-01)	1 powder	2011-03-21	0000-00-00	No	No	Current
65976-100-12	65976010012	1 POUCH in 1 BOX (65976-100-12) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY	1 pouch	2011-03-21	0000-00-00	No	No	Current
65976-100-24	65976010024	2 POUCH in 1 BOX (65976-100-24) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY	2 pouch	2011-03-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ARESTIN ® (minocycline hydrochloride) microspheres, 1 mg	OraPharma, Inc. \| Alcami Carolinas Corporation	2024-05-31	HUMAN PRESCRIPTION DRUG LABEL	21