Hydrocodone Bitatrate and Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Hydrocodone Bitartrate; Acetaminophen.
| Product ID | 55700-216_d9377108-02f5-41a6-ab2d-8cea27219cfe |
| NDC | 55700-216 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Hydrocodone Bitatrate and Acetaminophen |
| Generic Name | Hydrocodone Bitatrate And Acetaminophen |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-10-06 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA040148 |
| Labeler Name | Lake Erie Medical DBA Quality Care Products LLC |
| Substance Name | HYDROCODONE BITARTRATE; ACETAMINOPHEN |
| Active Ingredient Strength | 3 mg/1; mg/1 |
| Pharm Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2014-10-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA040148 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-10-06 |
| Marketing End Date | 2019-10-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040148 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-10-06 |
| Marketing End Date | 2019-10-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040148 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-10-06 |
| Marketing End Date | 2016-06-01 |
| Marketing Category | ANDA |
| Application Number | ANDA040148 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-10-06 |
| Marketing End Date | 2019-10-11 |
| Ingredient | Strength |
|---|---|
| HYDROCODONE BITARTRATE | 2.5 mg/1 |
| SPL SET ID: | 7221396f-4f3a-428a-9252-d451511b94e4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 55700-216 | Hydrocodone Bitatrate and Acetaminophen | Hydrocodone Bitatrate and Acetaminophen |
| 65084-453 | Hydrocodone Bitatrate and Acetaminophen | Hydrocodone Bitatrate and Acetaminophen |
| 52544-071 | Norco | Hydrocodone Bitatrate and Acetaminophen |
| 52544-161 | Norco | Hydrocodone Bitatrate and Acetaminophen |
| 52544-162 | Norco | Hydrocodone Bitatrate and Acetaminophen |
| 65084-288 | Norco | Hydrocodone Bitatrate and Acetaminophen |