Minocycline Hydrochloride

Product NDC: 64380-155
11-digit product format: 643800155
Labeler code: 64380
Product ID: 64380-155_73a30dc4-352b-4307-b902-07ffefc99a99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA065131
Marketing category: ANDA
Marketing start: 2022-04-11
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 75 mg/1
Pharmacologic classes: 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 · 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…`

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	75 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207362	Internal RxNorm lookup
207364	Internal RxNorm lookup
403840	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
d6e136ba-c9b1-4846-ae2a-98a29cb4504d	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
64380-155-01	Minocycline Hydrochloride	100 in 1 BOTTLE	TABLET	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-155-01	EA - Each	64380-155	1614803d-348a-4216-860c-655694e5570e	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-155	MINOCYCLINE HYDROCHLORIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]	2	Current NDC, Legacy NDC, 1 package rows	20220411_d6e136ba-c9b1-4846-ae2a-98a29cb4504d.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 ndc (product): 64380-155

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
207364	minocycline HCl 100 MG Oral Tablet	PSN	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2
207362	minocycline HCl 50 MG Oral Tablet	PSN	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2
403840	minocycline HCl 75 MG Oral Tablet	PSN	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2
207364	minocycline 100 MG Oral Tablet	SCD	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2
207362	minocycline 50 MG Oral Tablet	SCD	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2
403840	minocycline 75 MG Oral Tablet	SCD	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2
207364	minocycline (as minocycline hydrochloride) 100 MG Oral Tablet	SY	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2
207362	minocycline (as minocycline hydrochloride) 50 MG Oral Tablet	SY	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2
403840	minocycline (as minocycline hydrochloride) 75 MG Oral Tablet	SY	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-155-01	64380015501	100 TABLET in 1 BOTTLE (64380-155-01)	100 tablet	2022-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MINOCYCLINE HYDROCHLORIDE TABLETS, USP Rx Only	Strides Pharma Science Limited \| Strides Pharma Global Pte. Ltd. \| Strides Pharma, Inc	2022-03-31	HUMAN PRESCRIPTION DRUG LABEL	2