clindamycin hydrochloride

Generic: clindamycin hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin hydrochloride
Generic Name clindamycin hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

clindamycin hydrochloride 300 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-693
Product ID 63304-693_339366d4-2060-1c29-e063-6394a90a1cb7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065061
Listing Expiration 2026-12-31
Marketing Start 2001-03-23

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 63304693
Hyphenated Format 63304-693

Supplemental Identifiers

RxCUI
197518 284215
UPC
0363304693010
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 ANDA065061 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (63304-693-01)
  • 10 CAPSULE in 1 BOTTLE (63304-693-03)
  • 500 CAPSULE in 1 BOTTLE (63304-693-05)
  • 16 CAPSULE in 1 BOTTLE (63304-693-16)
  • 3 BLISTER PACK in 1 CARTON (63304-693-62) / 20 CAPSULE in 1 BLISTER PACK (63304-693-11)
  • 100 CAPSULE in 1 CARTON (63304-693-77)
source: ndc

Packages (6)

63304-693-01 100 CAPSULE in 1 BOTTLE (63304-693-01) 63304-693-03 10 CAPSULE in 1 BOTTLE (63304-693-03) 63304-693-05 500 CAPSULE in 1 BOTTLE (63304-693-05) 63304-693-16 16 CAPSULE in 1 BOTTLE (63304-693-16) 63304-693-62 3 BLISTER PACK in 1 CARTON (63304-693-62) / 20 CAPSULE in 1 BLISTER PACK (63304-693-11) 63304-693-77 100 CAPSULE in 1 CARTON (63304-693-77)

Ingredients (1)

clindamycin hydrochloride (300 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": "339366d4-2060-1c29-e063-6394a90a1cb7", "openfda": {"upc": ["0363304693010"], "unii": ["T20OQ1YN1W"], "rxcui": ["197518", "284215"], "spl_set_id": ["1dbd8448-c1e5-46df-8060-50ef82380445"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (63304-693-01)", "package_ndc": "63304-693-01", "marketing_start_date": "20010323"}, {"sample": false, "description": "10 CAPSULE in 1 BOTTLE (63304-693-03)", "package_ndc": "63304-693-03", "marketing_start_date": "20010323"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (63304-693-05)", "package_ndc": "63304-693-05", "marketing_start_date": "20010323"}, {"sample": false, "description": "16 CAPSULE in 1 BOTTLE (63304-693-16)", "package_ndc": "63304-693-16", "marketing_start_date": "20010323"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (63304-693-62)  / 20 CAPSULE in 1 BLISTER PACK (63304-693-11)", "package_ndc": "63304-693-62", "marketing_start_date": "20190101"}, {"sample": false, "description": "100 CAPSULE in 1 CARTON (63304-693-77)", "package_ndc": "63304-693-77", "marketing_start_date": "20010323"}], "brand_name": "Clindamycin hydrochloride", "product_id": "63304-693_339366d4-2060-1c29-e063-6394a90a1cb7", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "63304-693", "generic_name": "Clindamycin hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin hydrochloride", "active_ingredients": [{"name": "CLINDAMYCIN HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA065061", "marketing_category": "ANDA", "marketing_start_date": "20010323", "listing_expiration_date": "20261231"}