clindamycin in 5 percent dextrose

Generic: clindamycin in 5 percent dextrose

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clindamycin in 5 percent dextrose
Generic Name clindamycin in 5 percent dextrose
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

clindamycin 18 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9269
Product ID 0143-9269_0dbb7c39-4e79-4a6a-9f25-d4920b2e6562
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214401
Listing Expiration 2026-12-31
Marketing Start 2024-06-12

Pharmacologic Class

Established (EPC)
lincosamide antibacterial [epc]
Chemical Structure
lincosamides [cs]
Physiologic Effect
decreased sebaceous gland activity [pe] neuromuscular blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439269
Hyphenated Format 0143-9269

Supplemental Identifiers

RxCUI
309335 309336 309339
UNII
3U02EL437C
NUI
N0000009982 N0000175443 M0515779 N0000175731

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 in 5 percent dextrose (source: ndc)
Generic Name clindamycin in 5 percent dextrose (source: ndc)
Application Number ANDA214401 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 18 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0143-9269-01) / 50 mL in 1 VIAL
source: ndc

Packages (1)

0143-9269-01 1 VIAL in 1 CARTON (0143-9269-01) / 50 mL in 1 VIAL

Ingredients (1)

clindamycin (18 mg/mL)

Linked Drug Pages (1)

Clindamycin in 5 percent Dextrose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0dbb7c39-4e79-4a6a-9f25-d4920b2e6562", "openfda": {"nui": ["N0000009982", "N0000175443", "M0515779", "N0000175731"], "unii": ["3U02EL437C"], "rxcui": ["309335", "309336", "309339"], "spl_set_id": ["8b452032-abed-495b-b518-15623e9850a3"], "pharm_class_cs": ["Lincosamides [CS]"], "pharm_class_pe": ["Decreased Sebaceous Gland Activity [PE]", "Neuromuscular Blockade [PE]"], "pharm_class_epc": ["Lincosamide Antibacterial [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0143-9269-01)  / 50 mL in 1 VIAL", "package_ndc": "0143-9269-01", "marketing_start_date": "20240612"}], "brand_name": "Clindamycin in 5 percent Dextrose", "product_id": "0143-9269_0dbb7c39-4e79-4a6a-9f25-d4920b2e6562", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "0143-9269", "generic_name": "Clindamycin in 5 percent Dextrose", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clindamycin in 5 percent Dextrose", "active_ingredients": [{"name": "CLINDAMYCIN", "strength": "18 mg/mL"}], "application_number": "ANDA214401", "marketing_category": "ANDA", "marketing_start_date": "20240612", "listing_expiration_date": "20261231"}