HYDROCODONE BITARTATE AND ACETAMINOPHEN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Northwind Pharmaceuticals. The primary component is Hydrocodone Bitartrate; Acetaminophen.
| Product ID | 51655-900_7c60a4be-adaa-edd2-e053-2991aa0a917f |
| NDC | 51655-900 |
| Product Type | Human Prescription Drug |
| Proprietary Name | HYDROCODONE BITARTATE AND ACETAMINOPHEN |
| Generic Name | Hydrocodone Bitartate And Acetaminophen |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-05-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA090118 |
| Labeler Name | Northwind Pharmaceuticals |
| Substance Name | HYDROCODONE BITARTRATE; ACETAMINOPHEN |
| Active Ingredient Strength | 5 mg/1; mg/1 |
| Pharm Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2014-05-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA090118 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-05-01 |
| Marketing Category | ANDA |
| Application Number | ANDA090118 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-09-19 |
| Marketing Category | ANDA |
| Application Number | ANDA090118 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-05-01 |
| Marketing Category | ANDA |
| Application Number | ANDA090118 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-05-06 |
| Ingredient | Strength |
|---|---|
| HYDROCODONE BITARTRATE | 5 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0904-6419 | Hydrocodone Bitartate and Acetaminophen | Hydrocodone Bitartate and Acetaminophen |
| 33261-881 | Hydrocodone Bitartate and Acetaminophen | HYDROCODONE BITARTRATE, ACETAMINOPHEN |
| 42254-300 | Hydrocodone Bitartate and Acetaminophen | HYDROCODONE BITARTRATE, ACETAMINOPHEN |
| 51655-900 | HYDROCODONE BITARTATE AND ACETAMINOPHEN | HYDROCODONE BITARTATE AND ACETAMINOPHEN |
| 63629-5428 | Hydrocodone Bitartate and Acetaminophen | HYDROCODONE BITARTRATE, ACETAMINOPHEN |
| 76519-1011 | Hydrocodone Bitartate and Acetaminophen | HYDROCODONE BITARTRATE, ACETAMINOPHEN |