minocycline hydrochloride

Generic: minocycline hydrochloride

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name minocycline hydrochloride
Generic Name minocycline hydrochloride
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

minocycline hydrochloride 55 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-460
Product ID 68180-460_ad320f99-9382-4ef0-b6b6-86542020555a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091424
Listing Expiration 2026-12-31
Marketing Start 2019-02-22

Pharmacologic Class

Classes
decreased prothrombin activity [pe] tetracycline-class drug [epc] tetracyclines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180460
Hyphenated Format 68180-460

Supplemental Identifiers

RxCUI
629695 629697 629699 1013662
UPC
0368180460060
UNII
0020414E5U

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name minocycline hydrochloride (source: ndc)
Generic Name minocycline hydrochloride (source: ndc)
Application Number ANDA091424 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 55 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Minocycline hydrochloride extended-release tablets USP are supplied as aqueous film coated tablets containing minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 90 mg, or 135 mg minocycline. The 45 mg extended-release tablets are pink colored, round shaped, biconvex, film-coated tablets debossed with "F21" on one side and "LU" on the other side. Each tablet contains minocycline hydrochloride USP equivalent to 45 mg minocycline, supplied as follows: NDC 68180-379-06 Bottle of 30 NDC 68180-379-01 Bottle of 100 The 55 mg extended-release tablets are green colored, round shaped, biconvex, film-coated tablets debossed with "F26" on one side and "LU" on the other side. Each tablet contains minocycline hydrochloride equivalent to 55 mg minocycline, supplied as follows: NDC 68180-460-06 Bottle of 30 NDC 68180-460-01 Bottle of 100 The 90 mg extended-release tablets are pale yellow colored, round shaped, biconvex, film-coated tablets debossed with "F22" on one side and "LU" on the other side. Each tablet contains minocycline hydrochloride USP equivalent to 90 mg minocycline, supplied as follows: NDC 68180-380-06 Bottle of 30 NDC 68180-380-01 Bottle of 100 The 135 mg extended-release tablets are brown colored, capsule shaped, biconvex, film-coated tablets debossed with "F23" on one side and "LU" on the other side. Each tablet contains minocycline hydrochloride USP equivalent to 135 mg minocycline, supplied as follows: NDC 68180-381-06 Bottle of 30 NDC 68180-381-01 Bottle of 100 16.2 Storage Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. 16.3 Handling Keep out of reach of children. Protect from light, moisture, and excessive heat. Dispense in tight, light-resistant container with child-resistant closure.
  • PRINCIPAL DISPLAY PANEL MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 45 mg* NDC 68180-379-06 30 TABLETS MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 55 mg* NDC 68180-460-06 30 TABLETS MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 90 mg* NDC 68180-380-06 30 TABLETS MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 135 mg* NDC 68180-381-01 100 TABLETS 45 mg - 30s img 90 mg - 30s 125 mg - 30s
source: label

Packages (0)

No package records.

Ingredients (1)

minocycline hydrochloride (55 mg/1)

Linked Drug Pages (1)

Minocycline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ad320f99-9382-4ef0-b6b6-86542020555a", "openfda": {"upc": ["0368180460060"], "unii": ["0020414E5U"], "rxcui": ["629695", "629697", "629699", "1013662"], "spl_set_id": ["3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Minocycline Hydrochloride", "product_id": "68180-460_ad320f99-9382-4ef0-b6b6-86542020555a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Prothrombin Activity [PE]", "Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "68180-460", "generic_name": "Minocycline Hydrochloride", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Minocycline Hydrochloride", "active_ingredients": [{"name": "MINOCYCLINE HYDROCHLORIDE", "strength": "55 mg/1"}], "application_number": "ANDA091424", "marketing_category": "ANDA", "marketing_start_date": "20190222", "listing_expiration_date": "20261231"}