phenobarbital sodium

Generic: phenobarbital sodium

Labeler: nexus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name phenobarbital sodium
Generic Name phenobarbital sodium
Labeler nexus pharmaceuticals, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

phenobarbital sodium 130 mg/mL

Manufacturer
Nexus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 14789-128
Product ID 14789-128_45c7f956-27bd-dc6d-e063-6394a90a6181
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-12-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14789128
Hyphenated Format 14789-128

Supplemental Identifiers

RxCUI
2671204 2671207
UNII
SW9M9BB5K3

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 phenobarbital sodium (source: ndc)
Generic Name phenobarbital sodium (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 130 mg/mL
source: ndc
Packaging
  • HOW SUPPLIED Phenobarbital Sodium Injection, USP is available as follows: 65 mg/mL, 1 mL vials packaged in 10s (NDC 14789-127-05) 130 mg/mL, 1 mL vials packaged in 10s (NDC 14789-128-05) Storage Store at 20° to 25° C (68° to 77° F), excursions permitted to 15° to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Do not use if solution is discolored or contains a precipitate. To report SUSPECTED ADVERSE REACTIONS, contact Nexus Pharmaceuticals, LLC via Lambda Therapeutics Limited at 1-855-642-2594 or [email protected], or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured in Italy for: NEXUS PHARMACEUTICALS Nexus Pharmaceuticals, LLC Lincolnshire, IL 60069, USA PHBPI01ITR03 Revised: 06/2025 8022340
  • Principal Display Panel – 65 mg/mL Carton Label NDC 14789- 127 -05 Rx Only Phenobarbital Sodium Injection, USP CIV 65 mg/mL For Intramuscular or Slow Intravenous Use Only Do not use if discolored or contains a precipitate 10 x 1mL Single-dose Vials NEXUS PHARMACEUTICALS Principal Display Panel – 65 mg/mL Carton Label
  • Principal Display Panel - 65 mg/mL Vial Label NDC 14789- 127 -07 Rx Only Phenobarbital Sodium Injection, USP CIV 65 mg/mL CIV For Intramuscular or Slow Intravenous Use Do not use if discolored or precipitated 1 mL Single-dose Vial NEXUS PHARMACEUTICALS Principal Display Panel - 65 mg/mL Vial Label
  • Principal Display Panel – 130 mg/mL Carton Label NDC 14789- 128 -05 Rx Only Phenobarbital Sodium Injection, USP CIV 130 mg/mL For Intramuscular or Slow Intravenous Use Only Do not use if discolored or contains a precipitate 10 x 1mL Single-dose Vials NEXUS PHARMACEUTICALS Principal Display Panel – 130 mg/mL Carton Label
  • Principal Display Panel - 130 mg/mL Vial Label NDC 14789- 128 -07 Rx Only Phenobarbital Sodium Injection, USP CIV 130 mg/mL CIV For Intramuscular or Slow Intravenous Use Do not use if discolored or precipitated 1 mL Single-dose Vial NEXUS PHARMACEUTICALS Principal Display Panel - 130 mg/mL Vial Label
source: label

Packages (0)

No package records.

Ingredients (1)

phenobarbital sodium (130 mg/mL)

Linked Drug Pages (1)

Phenobarbital Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "45c7f956-27bd-dc6d-e063-6394a90a6181", "openfda": {"unii": ["SW9M9BB5K3"], "rxcui": ["2671204", "2671207"], "spl_set_id": ["472da201-698e-4d2b-8c53-595461d85bb6"], "manufacturer_name": ["Nexus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Phenobarbital Sodium", "product_id": "14789-128_45c7f956-27bd-dc6d-e063-6394a90a6181", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "14789-128", "dea_schedule": "CIV", "generic_name": "Phenobarbital Sodium", "labeler_name": "Nexus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenobarbital Sodium", "active_ingredients": [{"name": "PHENOBARBITAL SODIUM", "strength": "130 mg/mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20231206", "listing_expiration_date": "20261231"}