clindamycin hydrochloride

Generic: clindamycin hydrochloride

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin hydrochloride
Generic Name clindamycin hydrochloride
Labeler micro labs limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

clindamycin hydrochloride 75 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-250
Product ID 42571-250_4b9187bd-aae7-dfaa-e063-6294a90acfd6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207402
Listing Expiration 2027-12-31
Marketing Start 2019-01-07

Pharmacologic Class

Classes
decreased sebaceous gland activity [pe] lincosamide antibacterial [epc] lincosamides [cs] neuromuscular blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571250
Hyphenated Format 42571-250

Supplemental Identifiers

RxCUI
197518 284215 309329
UNII
T20OQ1YN1W

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 clindamycin hydrochloride (source: ndc)
Generic Name clindamycin hydrochloride (source: ndc)
Application Number ANDA207402 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42571-250-01)
  • 90 BLISTER PACK in 1 CARTON (42571-250-67) / 10 CAPSULE in 1 BLISTER PACK (42571-250-32)
source: ndc

Packages (2)

42571-250-01 100 CAPSULE in 1 BOTTLE (42571-250-01) 42571-250-67 90 BLISTER PACK in 1 CARTON (42571-250-67) / 10 CAPSULE in 1 BLISTER PACK (42571-250-32)

Ingredients (1)

clindamycin hydrochloride (75 mg/1)

Linked Drug Pages (1)

CLINDAMYCIN HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b9187bd-aae7-dfaa-e063-6294a90acfd6", "openfda": {"unii": ["T20OQ1YN1W"], "rxcui": ["197518", "284215", "309329"], "spl_set_id": ["9b9f898f-6a91-44f8-9508-f9ddfaad27bc"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42571-250-01)", "package_ndc": "42571-250-01", "marketing_start_date": "20190107"}, {"sample": false, "description": "90 BLISTER PACK in 1 CARTON (42571-250-67)  / 10 CAPSULE in 1 BLISTER PACK (42571-250-32)", "package_ndc": "42571-250-67", "marketing_start_date": "20190107"}], "brand_name": "CLINDAMYCIN HYDROCHLORIDE", "product_id": "42571-250_4b9187bd-aae7-dfaa-e063-6294a90acfd6", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "42571-250", "generic_name": "Clindamycin hydrochloride", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLINDAMYCIN HYDROCHLORIDE", "active_ingredients": [{"name": "CLINDAMYCIN HYDROCHLORIDE", "strength": "75 mg/1"}], "application_number": "ANDA207402", "marketing_category": "ANDA", "marketing_start_date": "20190107", "listing_expiration_date": "20271231"}