Minocycline Hydrochloride

Product NDC: 65862-557
11-digit product format: 658620557
Labeler code: 65862
Product ID: 65862-557_5569f0f6-b36f-4149-aee7-2699fa5ebe53
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA202261
Marketing category: ANDA
Marketing start: 2018-09-28
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 115 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	65862-557		UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	65862-557	65862-557-61	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 · 40 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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`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	65862-557-61	`263afe128892…`	`91768de4ddbe…`

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202261-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19
A202261-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28
A202261-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19
A202261-004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28
A202261-005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19
A202261-006	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13
A202261-007	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13
A202261-008	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A202261-001	AB
A202261-002	AB
A202261-003	AB
A202261-004	AB
A202261-005	AB
A202261-006	AB
A202261-007	AB
A202261-008	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 9 · 327 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	A202261-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-002	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-004	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-006	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-007	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-002	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-004	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-006	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-007	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202261-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-002	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-004	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-006	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-007	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-002	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-004	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-006	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-007	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-002	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-004	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-006	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-007	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-21	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 327 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	A202261-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202261-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202261-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202261-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202261-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202261-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202261-008	AB	1	`b8a1b40f171c…`

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	115 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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
629695	Internal RxNorm lookup
629697	Internal RxNorm lookup
629699	Internal RxNorm lookup
858062	Internal RxNorm lookup
858372	Internal RxNorm lookup
1013659	Internal RxNorm lookup
1013662	Internal RxNorm lookup
1013665	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
e7b88a48-12b3-461d-b356-0d7ae4e8fd44	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
23de08d7-aa4e-ec8b-ce6d-2124a855e4ef	Product name	5	20180605
76736e48-254d-4a39-993d-206efbdaad1d	Product name	1	20170717
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
0c498039-5512-d9d7-e6b6-833de47219ff	Product name	2	20151106
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65862-557-30	Minocycline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		10
65862-557-99	Minocycline Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	1000		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-557-30	EA - Each	65862-557	14c9f43d-6793-4908-b941-d97af741cb24	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINOCYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0020414E5U	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
MINOCYCLINE	ACTIVE MOIETY	FYY3R43WGO	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
HYPROMELLOSE 2208 (4000 MPA.S)	INACTIVE INGREDIENT	39J80LT57T	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-557	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]	10	Current NDC, Legacy NDC, 2 package rows	20250429_e7b88a48-12b3-461d-b356-0d7ae4e8fd44.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	Aurobindo Pharma Limited	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	2025-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202261 application number: ANDA202261 ndc (product): 65862-557

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
1013659	minocycline HCl 105 MG 24HR Extended Release Oral Tablet	PSN	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
858062	minocycline HCl 115 MG 24HR Extended Release Oral Tablet	PSN	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629695	minocycline HCl 135 MG 24HR Extended Release Oral Tablet	PSN	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629697	minocycline HCl 45 MG 24HR Extended Release Oral Tablet	PSN	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
1013662	minocycline HCl 55 MG 24HR Extended Release Oral Tablet	PSN	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
858372	minocycline HCl 65 MG 24HR Extended Release Oral Tablet	PSN	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
1013665	minocycline HCl 80 MG 24HR Extended Release Oral Tablet	PSN	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629699	minocycline HCl 90 MG 24HR Extended Release Oral Tablet	PSN	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
1013659	24 HR minocycline 105 MG Extended Release Oral Tablet	SCD	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
858062	24 HR minocycline 115 MG Extended Release Oral Tablet	SCD	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629695	24 HR minocycline 135 MG Extended Release Oral Tablet	SCD	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629697	24 HR minocycline 45 MG Extended Release Oral Tablet	SCD	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
1013662	24 HR minocycline 55 MG Extended Release Oral Tablet	SCD	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
858372	24 HR minocycline 65 MG Extended Release Oral Tablet	SCD	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
1013665	24 HR minocycline 80 MG Extended Release Oral Tablet	SCD	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629699	24 HR minocycline 90 MG Extended Release Oral Tablet	SCD	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
1013659	minocycline 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
1013659	minocycline 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
1013659	minocycline 105 MG 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
858062	minocycline 115 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
858062	minocycline 115 MG 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629695	minocycline 135 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629695	minocycline 135 MG 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629697	minocycline 45 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629697	minocycline 45 MG 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
1013662	minocycline 55 MG 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
858372	minocycline 65 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
858372	minocycline 65 MG 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
1013665	minocycline 80 MG 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629699	minocycline 90 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10
629699	minocycline 90 MG 24 HR Extended Release Oral Tablet	SY	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-557-30	65862055730	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-557-30)	2018-09-28	0000-00-00	No	No	Current
65862-557-61	65862055761	6000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (65862-557-61)	28-SEP-18				Current
65862-557-99	65862055799	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-557-99)	2018-09-28	0000-00-00	No	No	Current