Acetaminophen, Caffeine and Dihydrocodeine Bitartrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Atland Pharmaceuticals, Llc. The primary component is Acetaminophen; Caffeine; Dihydrocodeine Bitartrate.
| Product ID | 71993-300_9d4d2838-e33e-6544-e053-2a95a90aaf51 |
| NDC | 71993-300 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Acetaminophen, Caffeine and Dihydrocodeine Bitartrate |
| Generic Name | Acetaminophen, Caffeine And Dihydrocodeine Bitartrate |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-01-30 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204209 |
| Labeler Name | Atland Pharmaceuticals, LLC |
| Substance Name | ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE |
| Active Ingredient Strength | 325 mg/1; mg/1; mg/1 |
| Pharm Classes | 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 | 2021-12-31 |
| Marketing Start Date | 2020-01-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204209 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-01-30 |
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68047-720 | Acetaminophen, Caffeine and Dihydrocodeine Bitartrate | Acetaminophen, Caffeine and Dihydrocodeine Bitartrate |
| 71993-300 | Acetaminophen, Caffeine and Dihydrocodeine Bitartrate | Acetaminophen, Caffeine and Dihydrocodeine Bitartrate |
| 70362-730 | DVORAH | acetaminophen, caffeine and dihydrocodeine bitartrate |
| 70569-152 | DVORAH | acetaminophen, caffeine and dihydrocodeine bitartrate |