minocycline hydrochloride

Product NDC: 70934-097
Requested package NDC: 70934-097-20
11-digit product format: 709340097
Labeler code: 70934
Product ID: 70934-097_b96bcd58-7438-63fa-e053-2995a90a43d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: minocycline hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA063066
Marketing category: ANDA
Marketing start: 2018-04-05
Marketing end: 0000-00-00
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70934-097	70934-097-20	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
70934-097-20	2023-01-30	C162847	48780-1	ba0f9c33-5387-a910-e053-dadaa90a0b85	MINOCYCLINE HYDROCHLORIDE CAPSULES, USP
70934-097-20	2021-01-31	C162847	48780-1	ba0f9c33-5387-a910-e053-dadaa90a0b85	MINOCYCLINE HYDROCHLORIDE CAPSULES, USP
70934-097-20	2021-01-29	C162847	48780-1	ba0f9c33-5387-a910-e053-dadaa90a0b85	MINOCYCLINE HYDROCHLORIDE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70934-097-20	minocycline hydrochloride	20 in 1 BOTTLE, PLASTIC	CAPSULE	20		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70934-097-20	EA - Each	70934-097	88a6a359-568f-4791-9585-2b07bc1a31c8	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-097	MINOCYCLINE HYDROCHLORIDE CAPSULE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	3	Legacy NDC, 1 package rows	20210201_6d0c4dc4-43c2-6499-e053-2991aa0afbe4.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
197985	minocycline HCl 50 MG Oral Capsule	PSN	6d0c4dc4-43c2-6499-e053-2991aa0afbe4	3
197985	minocycline 50 MG Oral Capsule	SCD	6d0c4dc4-43c2-6499-e053-2991aa0afbe4	3
197985	minocycline (as minocycline HCl) 50 MG Oral Capsule	SY	6d0c4dc4-43c2-6499-e053-2991aa0afbe4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-097-20	70934009720	20 CAPSULE in 1 BOTTLE, PLASTIC (70934-097-20)	20 capsule	2018-04-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MINOCYCLINE HYDROCHLORIDE CAPSULES, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-21	HUMAN PRESCRIPTION DRUG LABEL	3