Minocycline Hydrochloride

Product NDC: 68180-380
11-digit product format: 681800380
Labeler code: 68180
Product ID: 68180-380_ad320f99-9382-4ef0-b6b6-86542020555a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline Hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA091424
Marketing category: ANDA
Marketing start: 2012-02-14
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 90 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

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	68180-380	68180-380-06	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 · 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091424-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30
A091424-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30
A091424-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30
A091424-004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A091424-001	AB
A091424-002	AB
A091424-003	AB
A091424-004	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 5 · 164 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	A091424-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091424-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091424-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091424-004	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091424-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091424-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091424-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091424-004	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091424-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091424-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091424-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091424-004	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091424-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091424-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091424-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091424-004	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091424-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091424-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091424-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091424-004	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091424-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091424-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091424-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091424-004	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091424-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091424-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091424-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091424-004	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091424-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091424-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091424-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091424-004	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091424-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091424-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091424-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091424-004	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091424-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091424-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091424-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091424-004	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2011-11-30	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A091424-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091424-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091424-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091424-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091424-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091424-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091424-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091424-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091424-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091424-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091424-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091424-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091424-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091424-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091424-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091424-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091424-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091424-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091424-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091424-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091424-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091424-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091424-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091424-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091424-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091424-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091424-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091424-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091424-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091424-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091424-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091424-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091424-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091424-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091424-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091424-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091424-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091424-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091424-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091424-004	AB	1	`d06236e962d9…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091424-002	PC	2019-08-21	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A091424-002	PC	2019-08-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091424-002	PC	2019-08-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091424-002	PC	2019-08-21	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINOCYCLINE HYDROCHLORIDE	90 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
629695	Internal RxNorm lookup
629697	Internal RxNorm lookup
629699	Internal RxNorm lookup
1013662	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
3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	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	Strength	SPL version
68180-380-01	Minocycline Hydrochloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		12
68180-380-06	Minocycline Hydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-380-06	EA - Each	68180-380	0534ca84-8d0a-470e-a72f-9f21970578c8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINOCYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0020414E5U	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
MINOCYCLINE	ACTIVE MOIETY	FYY3R43WGO	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-380	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]	12	Current NDC, Legacy NDC, 2 package rows	20231102_3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b.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	Lupin Pharmaceuticals, Inc.	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091424 application number: ANDA091424 ndc (product): 68180-380

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
629695	minocycline HCl 135 MG 24HR Extended Release Oral Tablet	PSN	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629697	minocycline HCl 45 MG 24HR Extended Release Oral Tablet	PSN	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
1013662	minocycline HCl 55 MG 24HR Extended Release Oral Tablet	PSN	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629699	minocycline HCl 90 MG 24HR Extended Release Oral Tablet	PSN	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629695	24 HR minocycline 135 MG Extended Release Oral Tablet	SCD	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629697	24 HR minocycline 45 MG Extended Release Oral Tablet	SCD	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
1013662	24 HR minocycline 55 MG Extended Release Oral Tablet	SCD	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629699	24 HR minocycline 90 MG Extended Release Oral Tablet	SCD	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629695	minocycline 135 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629695	minocycline 135 MG 24 HR Extended Release Oral Tablet	SY	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629697	minocycline 45 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629697	minocycline 45 MG 24 HR Extended Release Oral Tablet	SY	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
1013662	minocycline 55 MG 24 HR Extended Release Oral Tablet	SY	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629699	minocycline 90 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12
629699	minocycline 90 MG 24 HR Extended Release Oral Tablet	SY	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-380-01	68180038001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-380-01)	2012-02-14	0000-00-00	No	No	Current
68180-380-06	68180038006	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-380-06)	2012-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minocycline Hydrochloride	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2023-10-30	HUMAN PRESCRIPTION DRUG LABEL	12