Minocycline Hydrochloride

Product NDC: 65862-209
11-digit product format: 658620209
Labeler code: 65862
Product ID: 65862-209_2f124ba7-5911-4813-be26-f7f0438d129c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065470
Marketing category: ANDA
Marketing start: 2008-03-11
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: 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	65862-209		UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	65862-209	65862-209-26	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 · 42 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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`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	65862-209-26	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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	Approval date
A065470-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11
A065470-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11
A065470-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065470-001	AB
A065470-002	AB
A065470-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065470-002	MINOCYCLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	2008-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065470-003	MINOCYCLINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE / ORAL	AB	2008-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065470-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	2008-03-11	`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	A065470-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065470-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065470-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065470-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065470-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065470-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065470-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065470-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065470-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065470-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065470-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065470-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065470-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065470-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065470-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065470-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065470-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065470-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065470-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065470-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065470-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065470-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065470-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065470-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065470-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065470-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065470-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065470-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065470-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065470-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065470-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065470-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065470-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065470-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065470-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065470-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065470-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065470-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065470-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065470-001	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	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 · 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
9013ca48-15f2-43cd-a51d-91cf65c72a7c	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	SPL version
65862-209-01	Minocycline Hydrochloride	100 in 1 BOTTLE	CAPSULE	100	15
65862-209-05	Minocycline Hydrochloride	500 in 1 BOTTLE	CAPSULE	500	15
65862-209-99	Minocycline Hydrochloride	1000 in 1 BOTTLE	CAPSULE	1000	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-209-01	EA - Each	65862-209	096fef42-0694-4a8c-9292-aba06e6d0ca5	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 [AUROBINDO PHARMA LIMITED]	6
MINOCYCLINE	ACTIVE MOIETY	FYY3R43WGO	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-209	MINOCYCLINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	15	Current NDC, Legacy NDC, 3 package rows	20250426_9013ca48-15f2-43cd-a51d-91cf65c72a7c.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	caa99901-467c-4e99-b7e9-fbabdf5d118c	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	REMEDYREPACK INC.	0becbde8-6ec5-4830-a0d9-cfdb7b15eb84	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	bb3b9a7e-6724-4c2a-b3cb-236f522b31a8	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	A-S Medication Solutions	c96b1c5d-7004-4ee2-ad48-0ba963389f86	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Northwind Health Company, LLC	12559b29-6568-4b99-a16e-6a87038981f7	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Aurobindo Pharma Limited	9013ca48-15f2-43cd-a51d-91cf65c72a7c	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470 ndc (product): 65862-209
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	d00d9bc4-c764-4ec1-beb0-44668637bcfb	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a6224eeb-25be-4f1d-889f-809aaf338c8c	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	abaacdeb-2433-261a-e053-2995a90ae34e	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	192327c5-d2bc-1bd1-e063-6394a90a110b	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	4f904969-5af3-461e-b557-d03a1e5c7292	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065470 application number: ANDA065470

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	a6224eeb-25be-4f1d-889f-809aaf338c8c	102
197985	minocycline 50 MG Oral Capsule	SCD	a6224eeb-25be-4f1d-889f-809aaf338c8c	102
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	a6224eeb-25be-4f1d-889f-809aaf338c8c	102
197984	minocycline HCl 100 MG Oral Capsule	PSN	c96b1c5d-7004-4ee2-ad48-0ba963389f86	28
197985	minocycline HCl 50 MG Oral Capsule	PSN	c96b1c5d-7004-4ee2-ad48-0ba963389f86	28
197984	minocycline 100 MG Oral Capsule	SCD	c96b1c5d-7004-4ee2-ad48-0ba963389f86	28
197985	minocycline 50 MG Oral Capsule	SCD	c96b1c5d-7004-4ee2-ad48-0ba963389f86	28
197984	minocycline (as minocycline HCl) 100 MG Oral Capsule	SY	c96b1c5d-7004-4ee2-ad48-0ba963389f86	28
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	c96b1c5d-7004-4ee2-ad48-0ba963389f86	28
197984	minocycline HCl 100 MG Oral Capsule	PSN	9013ca48-15f2-43cd-a51d-91cf65c72a7c	15
197985	minocycline HCl 50 MG Oral Capsule	PSN	9013ca48-15f2-43cd-a51d-91cf65c72a7c	15
314108	minocycline HCl 75 MG Oral Capsule	PSN	9013ca48-15f2-43cd-a51d-91cf65c72a7c	15
197984	minocycline 100 MG Oral Capsule	SCD	9013ca48-15f2-43cd-a51d-91cf65c72a7c	15
197985	minocycline 50 MG Oral Capsule	SCD	9013ca48-15f2-43cd-a51d-91cf65c72a7c	15
314108	minocycline 75 MG Oral Capsule	SCD	9013ca48-15f2-43cd-a51d-91cf65c72a7c	15
197984	minocycline (as minocycline HCl) 100 MG Oral Capsule	SY	9013ca48-15f2-43cd-a51d-91cf65c72a7c	15
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	9013ca48-15f2-43cd-a51d-91cf65c72a7c	15
314108	minocycline (as minocycline hydrochloride) 75 MG Oral Capsule	SY	9013ca48-15f2-43cd-a51d-91cf65c72a7c	15
197985	minocycline HCl 50 MG Oral Capsule	PSN	b620fc3d-bada-a58f-e053-2995a90ab28d	3
197985	minocycline 50 MG Oral Capsule	SCD	b620fc3d-bada-a58f-e053-2995a90ab28d	3
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	b620fc3d-bada-a58f-e053-2995a90ab28d	3
197985	minocycline HCl 50 MG Oral Capsule	PSN	8a80a7b8-4068-5d38-e053-2995a90a3f1d	1
197985	minocycline 50 MG Oral Capsule	SCD	8a80a7b8-4068-5d38-e053-2995a90a3f1d	1
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	8a80a7b8-4068-5d38-e053-2995a90a3f1d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-209-01	65862020901	100 CAPSULE in 1 BOTTLE (65862-209-01)	100 capsule	2008-03-11	0000-00-00	No	No	Current
65862-209-05	65862020905	500 CAPSULE in 1 BOTTLE (65862-209-05)	500 capsule	2008-03-11	0000-00-00	No	No	Current
65862-209-26	65862020926	2500 CAPSULE in 1 BAG (65862-209-26)	2500 capsule	11-MAR-08				Current
65862-209-99	65862020999	1000 CAPSULE in 1 BOTTLE (65862-209-99)	1000 capsule	2008-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minocycline Hydrochloride Capsules, USP Rx only	A-S Medication Solutions	2026-02-19	Human Prescription Drug Label	28
Minocycline Hydrochloride Capsules, USP Rx only	Aurobindo Pharma Limited	2025-04-08	Human Prescription Drug Label	15
Minocycline Hydrochloride Capsules, USP Rx only	Bryant Ranch Prepack	2024-10-07	HUMAN PRESCRIPTION DRUG LABEL	102
Minocycline Hydrochloride Capsules, USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	3
Minocycline Hydrochloride Capsules, USP Rx only	NuCare Pharmaceuticals,Inc.	2022-01-14	HUMAN PRESCRIPTION DRUG LABEL	3
MINOCYCLINE HYDROCHLORIDE	Direct_Rx	2019-06-04	HUMAN PRESCRIPTION DRUG LABEL	1