Minocycline Hydrochloride

Product NDC: 42546-777
Requested package NDC: 42546-777-30
11-digit product format: 425460777
Labeler code: 42546
Product ID: 42546-777_68acdc1d-a4e9-48a8-b5d5-71a6681ae7ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: PruGen Pharmaceuticals
Application: ANDA202261
Marketing category: ANDA
Marketing start: 2012-11-19
Marketing end: 0000-00-00
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 135 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42546-777	42546-777-30	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 · 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 package	package	42546-777	42546-777-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42546-777	42546-777-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202261-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19
A202261-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28
A202261-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19
A202261-004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28
A202261-005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19
A202261-006	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13
A202261-007	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13
A202261-008	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A202261-001	AB
A202261-002	AB
A202261-003	AB
A202261-004	AB
A202261-005	AB
A202261-006	AB
A202261-007	AB
A202261-008	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 9 · 327 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
2026-02-19 14:30 UTC	2026-02	A202261-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-002	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-004	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-006	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-007	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-002	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-004	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-006	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-007	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202261-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-002	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-004	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-006	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-007	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-002	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-004	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-006	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-007	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-002	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-004	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-006	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-007	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 327 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	A202261-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202261-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-008	AB	1	`b8a1b40f171c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42546-777-30	EA - Each	42546-777	f9ba9ef3-ca09-4205-9f84-7f578c074f26	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINOCYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0020414E5U	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
MINOCYCLINE	ACTIVE MOIETY	FYY3R43WGO	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
HYPROMELLOSE 2208 (4000 MPA.S)	INACTIVE INGREDIENT	39J80LT57T	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PRUGEN PHARMACEUTICALS]	1

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	Aurobindo Pharma Limited	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	2025-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202261 application number: ANDA202261

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42546-777-30	42546077730	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42546-777-30)	2012-11-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minocycline Hydrochloride	PruGen Pharmaceuticals \| Aurobindo Pharma Limited	2022-04-12	Human Prescription Drug Label	7