butalbital and acetaminophen

Generic: butalbital and acetaminophen tablets

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name butalbital and acetaminophen
Generic Name butalbital and acetaminophen tablets
Labeler oceanside pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 300 mg/1, butalbital 50 mg/1

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-306
Product ID 68682-306_3f21cb4d-0b19-441c-a6df-2c3077e1fede
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090956
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2017-06-19

Pharmacologic Class

Established (EPC)
barbiturate [epc]
Chemical Structure
barbiturates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682306
Hyphenated Format 68682-306

Supplemental Identifiers

RxCUI
1249617
UPC
0368682306019
UNII
362O9ITL9D KHS0AZ4JVK
NUI
N0000175693 M0002177

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 butalbital and acetaminophen (source: ndc)
Generic Name butalbital and acetaminophen tablets (source: ndc)
Application Number ANDA090956 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (68682-306-01)
source: ndc

Packages (1)

68682-306-01 100 TABLET in 1 BOTTLE, PLASTIC (68682-306-01)

Ingredients (2)

acetaminophen (300 mg/1) butalbital (50 mg/1)

Linked Drug Pages (1)

Butalbital and Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f21cb4d-0b19-441c-a6df-2c3077e1fede", "openfda": {"nui": ["N0000175693", "M0002177"], "upc": ["0368682306019"], "unii": ["362O9ITL9D", "KHS0AZ4JVK"], "rxcui": ["1249617"], "spl_set_id": ["d2213ffd-18f6-45f5-9af7-690a977562c4"], "pharm_class_cs": ["Barbiturates [CS]"], "pharm_class_epc": ["Barbiturate [EPC]"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (68682-306-01)", "package_ndc": "68682-306-01", "marketing_start_date": "20170619"}], "brand_name": "Butalbital and Acetaminophen", "product_id": "68682-306_3f21cb4d-0b19-441c-a6df-2c3077e1fede", "dosage_form": "TABLET", "pharm_class": ["Barbiturate [EPC]", "Barbiturates [CS]"], "product_ndc": "68682-306", "dea_schedule": "CIII", "generic_name": "Butalbital and Acetaminophen tablets", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Butalbital and Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "300 mg/1"}, {"name": "BUTALBITAL", "strength": "50 mg/1"}], "application_number": "ANDA090956", "marketing_category": "ANDA", "marketing_start_date": "20170619", "listing_expiration_date": "20261231"}