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 |