Minocycline Hydrochloride

Product NDC: 0591-5695
11-digit product format: 005915695
Labeler code: 0591
Product ID: 0591-5695_2d74faa2-99c4-4f01-adc6-60110d2b24da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA063065
Marketing category: ANDA
Marketing start: 1993-05-01
Marketing end: 2027-07-31
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 100 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	0591-5695		UNFINISHED	Active or certified unfinished drug listing	2026-08-12
unfinished package	package	0591-5695	0591-5695-00	UNFINISHED	Active or certified unfinished drug listing	2026-08-12
unfinished package	package	0591-5695	0591-5695-77	UNFINISHED	Active or certified unfinished drug listing	2026-08-12

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 · 52 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0591-5695-77	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0591-5695-00	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0591-5695-77	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0591-5695-00	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0591-5695-77	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0591-5695-00	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0591-5695-77	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0591-5695-00	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0591-5695-77	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0591-5695-00	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0591-5695-77	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0591-5695-00	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0591-5695-77	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0591-5695-00	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0591-5695-77	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0591-5695-00	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0591-5695-77	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0591-5695-00	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0591-5695-77	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0591-5695-00	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0591-5695-00	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0591-5695-00	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0591-5695-00	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0591-5695-00	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	0591-5695-00	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	0591-5695-00	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	0591-5695-00	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	0591-5695-00	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	0591-5695-00	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0591-5695-00	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	0591-5695-00	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A063065-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB		1991-12-30
A063065-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1999-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A063065-001	AB
A063065-002	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 3 · 82 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	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063065-001	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	1991-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063065-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1999-06-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A063065-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A063065-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063065-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063065-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063065-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A063065-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063065-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063065-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063065-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063065-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063065-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063065-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063065-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063065-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063065-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063065-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063065-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063065-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063065-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A063065-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063065-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063065-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063065-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063065-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063065-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063065-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063065-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A063065-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063065-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063065-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063065-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A063065-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063065-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A063065-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063065-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A063065-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063065-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A063065-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063065-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A063065-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Minocycline Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINOCYCLINE HYDROCHLORIDE	100 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
197984	Internal RxNorm lookup
197985	Internal RxNorm lookup
314108	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
a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	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
0591-5695-50	Minocycline Hydrochloride	50 in 1 BOTTLE, PLASTIC	CAPSULE	50		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-5695-50	EA - Each	0591-5695	48a683af-f89a-4338-876f-c554e627c9cf	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 CAPSULE [ACTAVIS PHARMA, INC.]	15
MINOCYCLINE	ACTIVE MOIETY	FYY3R43WGO	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	15
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	15
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	15
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	15
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	15
MINOCYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0020414E5U	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
MINOCYCLINE	ACTIVE MOIETY	FYY3R43WGO	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	12
MINOCYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0020414E5U	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
MINOCYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0020414E5U	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
MINOCYCLINE	ACTIVE MOIETY	FYY3R43WGO	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
MINOCYCLINE	ACTIVE MOIETY	FYY3R43WGO	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MINOCYCLINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTION, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MINOCYCLINE HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-5695	MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]	21	Current NDC, Legacy NDC, 1 package rows	20241006_a5fc4d50-50b2-46e0-b722-4c6b2ec47d06.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	87a137c6-dd53-44d3-ab49-ef78ebed35c8	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063065 application number: ANDA063065
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	REMEDYREPACK INC.	6597bdc9-9e3a-4c11-8b39-27b47f863287	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063065 application number: ANDA063065
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Actavis Pharma, Inc.	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063065 application number: ANDA063065 ndc (product): 0591-5695
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	6f154720-706e-4177-8167-1bc893303f1b	2024-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063065 application number: ANDA063065
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2019-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063065 application number: ANDA063065

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
197984	minocycline HCl 100 MG Oral Capsule	PSN	87a137c6-dd53-44d3-ab49-ef78ebed35c8	27
197984	minocycline 100 MG Oral Capsule	SCD	87a137c6-dd53-44d3-ab49-ef78ebed35c8	27
197984	minocycline (as minocycline HCl) 100 MG Oral Capsule	SY	87a137c6-dd53-44d3-ab49-ef78ebed35c8	27
197984	minocycline HCl 100 MG Oral Capsule	PSN	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	23
197985	minocycline HCl 50 MG Oral Capsule	PSN	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	23
314108	minocycline HCl 75 MG Oral Capsule	PSN	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	23
197984	minocycline 100 MG Oral Capsule	SCD	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	23
197985	minocycline 50 MG Oral Capsule	SCD	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	23
314108	minocycline 75 MG Oral Capsule	SCD	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	23
197984	minocycline (as minocycline HCl) 100 MG Oral Capsule	SY	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	23
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	23
314108	minocycline (as minocycline hydrochloride) 75 MG Oral Capsule	SY	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	23
197984	minocycline HCl 100 MG Oral Capsule	PSN	4eca4036-ba54-408e-e054-00144ff8d46c	3
197984	minocycline 100 MG Oral Capsule	SCD	4eca4036-ba54-408e-e054-00144ff8d46c	3
197984	minocycline (as minocycline HCl) 100 MG Oral Capsule	SY	4eca4036-ba54-408e-e054-00144ff8d46c	3
197984	minocycline HCl 100 MG Oral Capsule	PSN	00bf1ab3-dd22-439d-85fb-966dbb76c900	2
197984	minocycline HCl 100 MG Oral Capsule	PSN	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2
197984	minocycline HCl 100 MG Oral Capsule	PSN	ec1be1bf-73bb-41c5-8fab-359a4cc53674	2
197985	minocycline HCl 50 MG Oral Capsule	PSN	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2
197984	minocycline 100 MG Oral Capsule	SCD	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2
197984	minocycline 100 MG Oral Capsule	SCD	ec1be1bf-73bb-41c5-8fab-359a4cc53674	2
197984	minocycline 100 MG Oral Capsule	SCD	00bf1ab3-dd22-439d-85fb-966dbb76c900	2
197985	minocycline 50 MG Oral Capsule	SCD	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2
197984	minocycline (as minocycline HCl) 100 MG Oral Capsule	SY	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2
197984	minocycline (as minocycline HCl) 100 MG Oral Capsule	SY	00bf1ab3-dd22-439d-85fb-966dbb76c900	2
197984	minocycline (as minocycline HCl) 100 MG Oral Capsule	SY	ec1be1bf-73bb-41c5-8fab-359a4cc53674	2
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2
197984	minocycline HCl 100 MG Oral Capsule	PSN	6597bdc9-9e3a-4c11-8b39-27b47f863287	1
197984	minocycline 100 MG Oral Capsule	SCD	6597bdc9-9e3a-4c11-8b39-27b47f863287	1
197984	minocycline (as minocycline HCl) 100 MG Oral Capsule	SY	6597bdc9-9e3a-4c11-8b39-27b47f863287	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-5695-00	00591569500	30210 CAPSULE in 1 BOX (0591-5695-00)	30210 capsule	30-DEC-91				Current
0591-5695-50	00591569550	50 CAPSULE in 1 BOTTLE, PLASTIC (0591-5695-50)	50 capsule	1993-05-01	0000-00-00	No	No	Current
0591-5695-77	00591569577	30210 CAPSULE in 1 CONTAINER (0591-5695-77)	30210 capsule	16-OCT-24				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minocycline Hydrochloride Capsules, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	28
Minocycline Hydrochloride Capsules, USP Rx only	REMEDYREPACK INC.	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	1
Minocycline Hydrochloride Capsules, USP Rx only	Actavis Pharma, Inc.	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL	23
Minocycline Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Minocycline Hydrochloride Capsules, USP Rx only	NuCare Pharmaceuticals,Inc.	2021-02-15	HUMAN PRESCRIPTION DRUG LABEL	2
Minocycline Hydrochloride Capsules, USP Rx only	Bryant Ranch Prepack	2019-06-13	HUMAN PRESCRIPTION DRUG LABEL	2
Minocycline Hydrochloride Capsules, USP Rx only	NuCare Pharmaceuticals,Inc.	2018-01-12	HUMAN PRESCRIPTION DRUG LABEL	1
Minocycline Hydrochloride Capsules, USP Rx only	A-S Medication Solutions	2017-12-20	HUMAN PRESCRIPTION DRUG LABEL	6
Minocycline Hydrochloride Capsules USP Revised: July 2014 Rx only	Aphena Pharma Solutions - Tennessee, LLC	2016-06-28	HUMAN PRESCRIPTION DRUG LABEL	1
Minocycline Hydrochloride Capsules USP Revised: June 2009 Rx only 190791	Dispensing Solution, Inc. \| PSS World Medical, Inc.	2013-06-25	HUMAN PRESCRIPTION DRUG LABEL	2
Minocycline Hydrochloride Capsules USP Revised: June 2009 Rx only 190791	Carilion Materials Management	2013-05-13	HUMAN PRESCRIPTION DRUG LABEL	2