Minocycline hydrochloride

Product NDC: 51655-753
Requested package NDC: 51655-753-26
11-digit product format: 516550753
Labeler code: 51655
Product ID: 51655-753_4a7ae1e2-034d-e158-e063-6394a90ad9e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA063011
Marketing category: ANDA
Marketing start: 2023-01-24
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A063011-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1992-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A063011-001	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 2 · 41 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	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A063011-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063011-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063011-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063011-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063011-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063011-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063011-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063011-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063011-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063011-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063011-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063011-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063011-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063011-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063011-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063011-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063011-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063011-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063011-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063011-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063011-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063011-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063011-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063011-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063011-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063011-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063011-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063011-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063011-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063011-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063011-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063011-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063011-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063011-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063011-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063011-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063011-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063011-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063011-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063011-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Minocycline hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINOCYCLINE HYDROCHLORIDE	50 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197985	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
f33fcfd2-b9ef-8e67-e053-2a95a90a0306	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-753-20	2026-01-29	C162847	48780-1	49896155-a344-586f-e063-e6dba90add90	Minocycline Hydrochloride Capsules, USP
51655-753-25	2026-01-29	C162847	48780-1	49896155-a344-586f-e063-e6dba90add90	Minocycline Hydrochloride Capsules, USP
51655-753-26	2026-01-29	C162847	48780-1	49896155-a344-586f-e063-e6dba90add90	Minocycline Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51655-753-20	Minocycline hydrochloride	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	4
51655-753-25	Minocycline hydrochloride	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	4
51655-753-26	Minocycline hydrochloride	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-753	MINOCYCLINE HYDROCHLORIDE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	3	Current NDC, 3 package rows	20240127_f33fcfd2-b9ef-8e67-e053-2a95a90a0306.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Northwind Health Company, LLC	f33fcfd2-b9ef-8e67-e053-2a95a90a0306	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063011 application number: ANDA063011 ndc (package): 51655-753-26 ndc (product): 51655-753 ndc11 (package): 51655075326
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	25acb785-6838-4e62-9e86-ddc30b2b759a	2025-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063011 application number: ANDA063011
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Lifesciences Limited	26ee99af-f44b-4076-a08c-0a0dedc9edfe	2024-10-03		Exact identifier application applno (ANDA): 063011 application number: ANDA063011

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
197985	minocycline HCl 50 MG Oral Capsule	PSN	f33fcfd2-b9ef-8e67-e053-2a95a90a0306	4
197985	minocycline 50 MG Oral Capsule	SCD	f33fcfd2-b9ef-8e67-e053-2a95a90a0306	4
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	f33fcfd2-b9ef-8e67-e053-2a95a90a0306	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-753-26	51655075326	90 CAPSULE in 1 BOTTLE, PLASTIC (51655-753-26)	90 capsule	2023-07-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minocycline Hydrochloride Capsules, USP	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4