Minolira Extended Release

Product NDC: 71403-101
11-digit product format: 714030101
Labeler code: 71403
Product ID: 71403-101_40cf85be-00c6-4c01-b09d-5d336eb55227
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: EPI Health, Inc
Application: NDA209269
Marketing category: NDA
Marketing start: 2019-03-15
Marketing end: 0000-00-00
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 105 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71403-101		I	Inactivated by FDA	2026-08-03
excluded package	package	71403-101	71403-101-05	I	Inactivated by FDA	2026-08-03
excluded package	package	71403-101	71403-101-30	I	Inactivated by FDA	2026-08-03

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 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71403-101-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71403-101-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71403-101-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71403-101-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71403-101-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71403-101-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71403-101-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71403-101-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71403-101-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71403-101-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71403-101-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71403-101-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71403-101-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71403-101-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71403-101-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71403-101-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71403-101-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71403-101-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71403-101-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71403-101-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71403-101-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71403-101-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71403-101-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71403-101-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71403-101-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71403-101-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71403-101-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71403-101-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71403-101-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71403-101-05	`1332a3947898…`	`d4bfe170f9cd…`

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
N209269-001	MINOLIRA	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL			2017-05-08
N209269-002	MINOLIRA	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL			2017-05-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209269-001	11103517	2036-04-07		Drug product	2021-09-02
N209269-002	11103517	2036-04-07		Drug product	2021-09-02

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209269-001	MINOLIRA	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL		2017-05-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209269-002	MINOLIRA	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	RS	2017-05-08	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209269-001	11103517	2036-04-07	Drug product	2021-09-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209269-002	11103517	2036-04-07	Drug product	2021-09-02	`6a51e52b5d6a…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71403-101-05	2023-07-28	C162847	48780-1	0191ceaa-63d3-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use MINOLIRA™ safely and effectively. See full prescribing information for MINOLIRA. MINOLIRA™ (minocycline hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 1971
71403-101-30	2023-07-28	C162847	48780-1	0191ceaa-63d3-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use MINOLIRA™ safely and effectively. See full prescribing information for MINOLIRA. MINOLIRA™ (minocycline hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 1971

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71403-101-05	Minolira Extended Release	1 in 1 CARTON	TABLET	1	4
71403-101-05	Minolira Extended Release	5 in 1 BOTTLE	TABLET	5	4
71403-101-30	Minolira Extended Release	1 in 1 CARTON	TABLET	1	4
71403-101-30	Minolira Extended Release	30 in 1 BOTTLE	TABLET	30	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71403-101-30	EA - Each	71403-101	30f85b9e-7c1a-4d29-8863-c658c9fcb273	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71403-101	MINOLIRA EXTENDED RELEASE (MINOCYCLINE HYDROCHLORIDE) TABLET [EPI HEALTH, INC]	4	Legacy NDC, 4 package rows	20221208_523856a4-530b-4a23-a80a-d72ab08e2c08.zip

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	523856a4-530b-4a23-a80a-d72ab08e2c08	4
629695	minocycline HCl 135 MG 24HR Extended Release Oral Tablet	PSN	523856a4-530b-4a23-a80a-d72ab08e2c08	4
1941489	minolira 105 MG 24HR Extended Release Oral Tablet	PSN	523856a4-530b-4a23-a80a-d72ab08e2c08	4
2058529	minolira 135 MG 24HR Extended Release Oral Tablet	PSN	523856a4-530b-4a23-a80a-d72ab08e2c08	4
1941489	24 HR minocycline 105 MG Extended Release Oral Tablet [Minolira]	SBD	523856a4-530b-4a23-a80a-d72ab08e2c08	4
2058529	24 HR minocycline 135 MG Extended Release Oral Tablet [Minolira]	SBD	523856a4-530b-4a23-a80a-d72ab08e2c08	4
1013659	24 HR minocycline 105 MG Extended Release Oral Tablet	SCD	523856a4-530b-4a23-a80a-d72ab08e2c08	4
629695	24 HR minocycline 135 MG Extended Release Oral Tablet	SCD	523856a4-530b-4a23-a80a-d72ab08e2c08	4
1013659	minocycline 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral Tablet	SY	523856a4-530b-4a23-a80a-d72ab08e2c08	4
1013659	minocycline 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral Tablet	SY	523856a4-530b-4a23-a80a-d72ab08e2c08	4
1013659	minocycline 105 MG 24 HR Extended Release Oral Tablet	SY	523856a4-530b-4a23-a80a-d72ab08e2c08	4
629695	minocycline 135 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	523856a4-530b-4a23-a80a-d72ab08e2c08	4
629695	minocycline 135 MG 24 HR Extended Release Oral Tablet	SY	523856a4-530b-4a23-a80a-d72ab08e2c08	4
1941489	Minolira 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral Tablet	SY	523856a4-530b-4a23-a80a-d72ab08e2c08	4
1941489	Minolira 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral Tablet	SY	523856a4-530b-4a23-a80a-d72ab08e2c08	4
1941489	Minolira 105 MG 24 HR Extended Release Oral Tablet	SY	523856a4-530b-4a23-a80a-d72ab08e2c08	4
2058529	Minolira 135 MG 24 HR Extended Release Oral Tablet	SY	523856a4-530b-4a23-a80a-d72ab08e2c08	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71403-101-05	71403010105	1 BOTTLE in 1 CARTON (71403-101-05) > 5 TABLET in 1 BOTTLE	1 bottle	2019-03-15	0000-00-00	No	No	Current
71403-101-30	71403010130	1 BOTTLE in 1 CARTON (71403-101-30) > 30 TABLET in 1 BOTTLE	1 bottle	2019-03-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minolira Extended Release	EPI Health, Inc \| EPI Health, Inc.	2022-11-02	HUMAN PRESCRIPTION DRUG LABEL	4