Minocycline

Product NDC: 42291-589
11-digit product format: 422910589
Labeler code: 42291
Product ID: 42291-589_ef693bed-1f22-ae2e-e053-2995a90ad5ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA065131
Marketing category: ANDA
Marketing start: 2015-05-08
Marketing end: 0000-00-00
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 50 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	42291-589		D	Discontinued by firm		2026-08-11
excluded package	package	42291-589	42291-589-90	D	Discontinued by firm		2026-08-11

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 · 4 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	42291-589-90	`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	42291-589-90	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065131-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16
A065131-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16
A065131-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065131-001	AB
A065131-002	AB
A065131-003	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 4 · 123 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	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065131-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2003-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065131-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	RS	2003-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065131-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB		2003-04-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A065131-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065131-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065131-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065131-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065131-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065131-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065131-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065131-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065131-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065131-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065131-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065131-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065131-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065131-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065131-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065131-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065131-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065131-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065131-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065131-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065131-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065131-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065131-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065131-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065131-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065131-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065131-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065131-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065131-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065131-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065131-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065131-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065131-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065131-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065131-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065131-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065131-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065131-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065131-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065131-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-589-90	EA - Each	42291-589	3a5064fe-60f1-4c34-84e5-0f9a63df3b94	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINOCYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0020414E5U	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1
MINOCYCLINE	ACTIVE MOIETY	FYY3R43WGO	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MINOCYCLINE (MINOCYCLINE) TABLET [AVKARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-589	MINOCYCLINE TABLET [AVKARE]	8	Legacy NDC	20240709_ad8678de-ee78-d061-ea5f-d2a6b949b0e5.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
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Strides Pharma Science Limited	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2022-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065131 application number: ANDA065131

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0020414E5U	MINOCYCLINE HYDROCHLORIDE	13614-98-7	MINOCYCLINE HYDROCHLORIDE
FYY3R43WGO	MINOCYCLINE	10118-90-8	Minocycline

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-589-90	42291058990	90 TABLET in 1 BOTTLE (42291-589-90)	90 tablet	2015-05-08	0000-00-00	No	No	Current