Hydrocodone Bitartrate and Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j Harkins Co., Inc. The primary component is Hydrocodone Bitartrate; Acetaminophen.
| Product ID | 52959-737_76c916a4-b168-2429-e053-2991aa0a52cc |
| NDC | 52959-737 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Hydrocodone Bitartrate and Acetaminophen |
| Generic Name | Hydrocodone Bitartrate And Acetaminophen |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-12-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA040736 |
| Labeler Name | H.J Harkins Co., Inc |
| 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 | 2019-12-31 |
| Marketing Start Date | 2017-12-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-12-30 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2010-01-18 |
| Inactivation Date | 2019-11-13 |
| Reactivation Date | 2019-11-13 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-11 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040736 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-11 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| HYDROCODONE BITARTRATE | 5 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0121-0772 | Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| 0121-1544 | Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| 0121-2316 | Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| 0121-4772 | Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| 0245-0410 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 68071-4801 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 68084-895 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 68084-884 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 68084-863 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen |
| 68094-714 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 68387-230 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| 68387-235 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 68788-6352 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 68788-9137 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen |
| 68788-9141 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen |
| 68788-9125 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen |
| 68788-9297 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 68788-9250 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0527-1647 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0527-1649 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0527-1648 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0527-1651 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0527-1646 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0527-1650 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 69101-600 | HYDROCODONE BITARTRATE and ACETAMINOPHEN | HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| 0591-2174 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0591-2175 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0591-2171 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0591-2605 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0591-2612 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0591-2172 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0591-2176 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0603-3887 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen |
| 0603-3890 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen |
| 0603-3891 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen |
| 71335-0063 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| 71335-0108 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 71335-0385 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| 71335-0466 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 71335-0960 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 71930-020 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 71930-019 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 71930-021 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 76519-1079 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| 75921-881 | Hydrocodone Bitartrate And Acetaminophen | Hydrocodone Bitartrate And Acetaminophen |
| 76519-1081 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| 0713-0704 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0904-6421 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0904-6420 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |
| 0904-6567 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen |