Butalbital, Aspirin, Caffeine, and Codeine Phosphate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma Inc.. The primary component is Butalbital; Aspirin; Caffeine; Codeine Phosphate.
Product ID | 68308-312_32e499ea-9f5f-44ad-97cc-7ca708c76135 |
NDC | 68308-312 |
Product Type | Human Prescription Drug |
Proprietary Name | Butalbital, Aspirin, Caffeine, and Codeine Phosphate |
Generic Name | Butalbital, Aspirin, Caffeine, And Codeine Phosphate |
Dosage Form | Capsule |
Route of Administration | ORAL |
Marketing Start Date | 2015-10-30 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA203335 |
Labeler Name | Mayne Pharma Inc. |
Substance Name | BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE |
Active Ingredient Strength | 50 mg/1; mg/1; mg/1; mg/1 |
Pharm Classes | Barbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule | CIII |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2015-10-30 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA203335 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2015-10-30 |
Ingredient | Strength |
---|---|
BUTALBITAL | 50 mg/1 |
SPL SET ID: | 3dd63865-af88-4cfe-a028-a21b3e65c25d |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
Pharm Class PE | |
PHarm Class EPC | |
UPC Code | |
NUI Code |
NDC | Brand Name | Generic Name |
---|---|---|
68308-312 | Butalbital, Aspirin, Caffeine, and Codeine Phosphate | Butalbital, Aspirin, Caffeine, and Codeine Phosphate |
51991-074 | Ascomp with Codeine | BUTALBITAL, ASPIRIN, CAFFEINE, and CODEINE PHOSPHATE |
0023-6010 | Fiorinal with Codeine | Butalbital, Aspirin, Caffeine, and Codeine Phosphate |
52544-956 | Fiorinal with Codeine | Butalbital, Aspirin, Caffeine, and Codeine Phosphate |