minocycline hydrochloride

Product NDC: 68382-535
Requested package NDC: 68382-535-10
11-digit product format: 683820535
Labeler code: 68382
Product ID: 68382-535_d984bc89-8412-45fd-ba75-e707bc53ae3d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: minocycline hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA203553
Marketing category: ANDA
Marketing start: 2018-03-07
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 135 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

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	Approval date
A203553-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16
A203553-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16
A203553-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16
A203553-004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16
A203553-005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16
A203553-006	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16
A203553-007	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16
A203553-008	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16

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 7 · 268 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203553-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203553-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203553-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203553-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203553-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203553-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203553-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203553-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203553-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203553-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203553-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203553-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203553-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203553-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203553-002	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203553-003	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203553-004	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203553-005	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203553-006	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203553-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	2023-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203553-008	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	2017-11-16	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 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	A203553-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203553-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203553-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203553-006	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203553-008	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203553-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203553-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203553-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203553-006	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203553-008	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203553-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203553-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203553-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203553-006	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203553-008	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203553-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203553-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203553-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203553-006	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203553-008	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203553-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203553-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203553-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203553-006	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203553-008	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203553-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203553-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203553-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203553-006	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203553-008	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203553-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203553-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203553-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203553-006	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203553-008	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203553-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203553-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203553-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203553-006	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203553-008	AB	1	`5aa47cf7b7d7…`

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	135 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
85f082a5-bba1-4441-ba28-4b8ec9a537f2	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	SPL version
68382-535-01	minocycline hydrochloride	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	5
68382-535-05	minocycline hydrochloride	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	5
68382-535-06	minocycline hydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	5
68382-535-10	minocycline hydrochloride	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	5
68382-535-16	minocycline hydrochloride	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	5
68382-535-30	minocycline hydrochloride	10 in 1 CARTON	TABLET, EXTENDED RELEASE	10	5
68382-535-30	minocycline hydrochloride	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-535	MINOCYCLINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	2	Current NDC, Legacy NDC, 7 package rows	20191228_85f082a5-bba1-4441-ba28-4b8ec9a537f2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Lifesciences Limited	8bf9cf23-8ffc-401f-981d-4878d694a468	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203553 application number: ANDA203553
minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	85f082a5-bba1-4441-ba28-4b8ec9a537f2	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203553 application number: ANDA203553 ndc (package): 68382-535-10 ndc (product): 68382-535 ndc11 (package): 68382053510

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	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
858062	minocycline HCl 115 MG 24HR Extended Release Oral Tablet	PSN	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629695	minocycline HCl 135 MG 24HR Extended Release Oral Tablet	PSN	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629697	minocycline HCl 45 MG 24HR Extended Release Oral Tablet	PSN	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
1013662	minocycline HCl 55 MG 24HR Extended Release Oral Tablet	PSN	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
858372	minocycline HCl 65 MG 24HR Extended Release Oral Tablet	PSN	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
1013665	minocycline HCl 80 MG 24HR Extended Release Oral Tablet	PSN	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629699	minocycline HCl 90 MG 24HR Extended Release Oral Tablet	PSN	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
1013659	24 HR minocycline 105 MG Extended Release Oral Tablet	SCD	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
858062	24 HR minocycline 115 MG Extended Release Oral Tablet	SCD	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629695	24 HR minocycline 135 MG Extended Release Oral Tablet	SCD	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629697	24 HR minocycline 45 MG Extended Release Oral Tablet	SCD	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
1013662	24 HR minocycline 55 MG Extended Release Oral Tablet	SCD	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
858372	24 HR minocycline 65 MG Extended Release Oral Tablet	SCD	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
1013665	24 HR minocycline 80 MG Extended Release Oral Tablet	SCD	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629699	24 HR minocycline 90 MG Extended Release Oral Tablet	SCD	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
1013659	minocycline 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
1013659	minocycline 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
1013659	minocycline 105 MG 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
858062	minocycline 115 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
858062	minocycline 115 MG 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629695	minocycline 135 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629695	minocycline 135 MG 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629697	minocycline 45 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629697	minocycline 45 MG 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
1013662	minocycline 55 MG 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
858372	minocycline 65 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
858372	minocycline 65 MG 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
1013665	minocycline 80 MG 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629699	minocycline 90 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5
629699	minocycline 90 MG 24 HR Extended Release Oral Tablet	SY	85f082a5-bba1-4441-ba28-4b8ec9a537f2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-535-10	68382053510	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-535-10)	2018-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	2025-06-05	HUMAN PRESCRIPTION DRUG LABEL	5