minocycline hydrochloride

Product NDC: 47781-544
11-digit product format: 477810544
Labeler code: 47781
Product ID: 47781-544_3ee915be-d5ee-3805-1ad9-092264ecfffd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: minocycline hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Alvogen, Inc.
Application: ANDA063067
Marketing category: ANDA
Marketing start: 2017-10-31
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	47781-544		D	Discontinued by firm		2026-10-05
excluded package	package	47781-544	47781-544-01	D	Discontinued by firm		2026-10-05

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 · 24 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	47781-544-01	`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	47781-544-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	47781-544-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	47781-544-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	47781-544-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	47781-544-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	47781-544-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	47781-544-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	47781-544-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	47781-544-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	47781-544-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	47781-544-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A063067-001	DYNACIN	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31
A063067-002	DYNACIN	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15
A063067-003	DYNACIN	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063067-002	DYNACIN	EQ 75MG BASE	CAPSULE / ORAL	1999-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063067-003	DYNACIN	EQ 50MG BASE	CAPSULE / ORAL	1990-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063067-001	DYNACIN	EQ 100MG BASE	CAPSULE / ORAL	1990-07-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063067-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063067-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063067-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063067-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063067-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063067-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063067-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063067-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063067-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063067-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063067-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063067-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063067-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063067-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063067-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063067-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063067-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063067-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063067-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063067-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063067-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063067-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A063067-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A063067-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063067-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A063067-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A063067-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063067-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A063067-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A063067-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063067-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A063067-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A063067-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063067-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A063067-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A063067-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063067-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A063067-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A063067-003	AB	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063067-001	AB	1	`a72a2bbeb626…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-544-01	EA - Each	47781-544	f7d9505e-a8e4-4688-a7b7-a834736830ab	1	2017-11-06

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	7453b4f2-f8a9-443c-8c21-d8c6d173cbe4	9
197985	minocycline 50 MG Oral Capsule	SCD	7453b4f2-f8a9-443c-8c21-d8c6d173cbe4	9
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	7453b4f2-f8a9-443c-8c21-d8c6d173cbe4	9
197985	minocycline HCl 50 MG Oral Capsule	PSN	6d0c4dc4-43c2-6499-e053-2991aa0afbe4	3
197985	minocycline 50 MG Oral Capsule	SCD	6d0c4dc4-43c2-6499-e053-2991aa0afbe4	3
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	6d0c4dc4-43c2-6499-e053-2991aa0afbe4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-544-01	47781054401	100 CAPSULE in 1 BOTTLE (47781-544-01)	100 capsule	2017-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MINOCYCLINE HYDROCHLORIDE CAPSULES, USP	Alvogen, Inc.	2023-07-18	HUMAN PRESCRIPTION DRUG LABEL	10
MINOCYCLINE HYDROCHLORIDE CAPSULES, USP	A-S Medication Solutions	2021-11-11	HUMAN PRESCRIPTION DRUG LABEL	9
MINOCYCLINE HYDROCHLORIDE CAPSULES, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-21	HUMAN PRESCRIPTION DRUG LABEL	3