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FDA Drug information

Minocycline hydrochloride

Read time: 1 mins
Marketing start date: 30 Apr 2024

Summary of product characteristics


Effective Time

20221101

Version

5

Spl Product Data Elements

Minocycline hydrochloride Minocycline hydrochloride MINOCYCLINE HYDROCHLORIDE MINOCYCLINE STARCH, CORN MAGNESIUM STEARATE GELATIN TITANIUM DIOXIDE D&C RED NO. 33 FD&C RED NO. 3 FD&C YELLOW NO. 6 FERROSOFERRIC OXIDE PROPYLENE GLYCOL D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 SHELLAC AMMONIA ALUMINUM OXIDE pink body and cap CAPSULE 316 Minocycline hydrochloride Minocycline hydrochloride MINOCYCLINE HYDROCHLORIDE MINOCYCLINE ALUMINUM OXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN MAGNESIUM STEARATE PROPYLENE GLYCOL SHELLAC STARCH, CORN TITANIUM DIOXIDE light gray opaque body and white opaque cap CAPSULE 317 Minocycline hydrochloride Minocycline hydrochloride MINOCYCLINE HYDROCHLORIDE MINOCYCLINE ALUMINUM OXIDE AMMONIA D&C RED NO. 28 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 FERRIC OXIDE RED FERROSOFERRIC OXIDE GELATIN MAGNESIUM STEARATE PROPYLENE GLYCOL SHELLAC STARCH, CORN TITANIUM DIOXIDE pink body and maroon cap CAPSULE 318

Application Number

ANDA063009

Brand Name

Minocycline hydrochloride

Generic Name

Minocycline hydrochloride

Product Ndc

70771-1427

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1426-1 Minocycline Hydrochloride Capsules USP, 50 mg 100 Capsules Rx only NDC 70771-1427-1 Minocycline Hydrochloride Capsules USP, 75 mg 100 Capsules Rx only NDC 70771-1428-7 Minocycline Hydrochloride Capsules USP, 100 mg 50 Capsules Rx only mino 50mg SEZ Minocycline Capsules, 75 mg mino 100mg SEZ

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