Label: MINOCYCLINE HYDROCHLORIDE capsule
- NDC Code(s): 61919-270-20, 61919-270-30
- Packager: DirectRX
- This is a repackaged label.
- Source NDC Code(s): 13668-484
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 17, 2023
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SPL Unclassified
Rx only
To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
- Description
- Clinical Pharmacology
- INDICATIONS & USAGE
- Contraindications
- Warnings
- Precautions
- Adverse Reactions
- Overdosage
- Dosage and Administration
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- Patient Information
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-270(NDC:13668-484) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO) MINOCYCLINE 100 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SHELLAC (UNII: 46N107B71O) GELATIN (UNII: 2G86QN327L) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color gray (gray opaque cap, white opaque body) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code RX696 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-270-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2018 2 NDC:61919-270-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065062 03/14/2018 Labeler - DirectRX (079254320) Establishment Name Address ID/FEI Business Operations DirectRX 079254320 repack(61919-270)
