Butalbital, Acetaminophen, Caffeine and Codeine Phosphate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Butalbital; Acetaminophen; Caffeine; Codeine Phosphate.
| Product ID | 71335-0194_0bfdc019-7caa-426a-b62b-3158269836d6 |
| NDC | 71335-0194 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate |
| Generic Name | Butalbital, Acetaminophen, Caffeine And Codeine Phosphate |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2004-07-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA076560 |
| Labeler Name | Bryant Ranch Prepack |
| Substance Name | BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE |
| Active Ingredient Strength | 50 mg/1; mg/1; mg/1; mg/1 |
| Pharm Classes | Barbiturates [CS],Barbiturate [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 | 2019-12-31 |
| Marketing Start Date | 2021-12-27 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA076560 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-09-01 |
| Marketing Category | ANDA |
| Application Number | ANDA076560 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-09-01 |
| Marketing Category | ANDA |
| Application Number | ANDA076560 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-09-01 |
| Marketing Category | ANDA |
| Application Number | ANDA076560 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-09-01 |
| Marketing Category | ANDA |
| Application Number | ANDA076560 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-09-01 |
| Marketing Category | ANDA |
| Application Number | ANDA076560 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-09-01 |
| Marketing Category | ANDA |
| Application Number | ANDA076560 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-09-01 |
| Ingredient | Strength |
|---|---|
| BUTALBITAL | 50 mg/1 |
| SPL SET ID: | 15a34df5-e48f-4570-9232-80e4093c4624 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0650 | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate |
| 0054-3000 | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate |
| 51991-073 | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate |
| 68258-2012 | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate |
| 71335-0194 | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital, Acetaminophen, Caffeine and Codeine Phosphate |