Butalbital, Acetaminophen, Caffeine and Codeine Phosphate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Acetaminophen; Butalbital; Caffeine; Codeine Phosphate.
| Product ID | 0054-3000_604e214c-d5fb-4061-9a88-b582d3a45f28 |
| NDC | 0054-3000 |
| 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 | 2022-05-09 |
| Marketing Category | ANDA / |
| Application Number | ANDA215138 |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Substance Name | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
| Active Ingredient Strength | 325 mg/1; mg/1; mg/1; mg/1 |
| Pharm Classes | Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS] |
| DEA Schedule | CIII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-05-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| 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 |