Hydrocodone Bitartate and Acetaminophen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Hydrocodone Bitartrate; Acetaminophen.
| Product ID | 76519-1011_76cc5b00-20a5-062c-e053-2a91aa0a1f89 |
| NDC | 76519-1011 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Hydrocodone Bitartate and Acetaminophen |
| Generic Name | Hydrocodone Bitartrate, Acetaminophen |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-05-17 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA040846 |
| Labeler Name | H.J. Harkins Company, Inc. |
| 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 | 2012-05-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA040846 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-05-17 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040846 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-05-17 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040846 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-05-17 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040846 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-05-17 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040846 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-05-17 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040846 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-05-17 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040846 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-05-17 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040846 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-05-17 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040846 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-05-17 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040846 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-05-17 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| HYDROCODONE BITARTRATE | 2.5 mg/1 |
| SPL SET ID: | 4f505b2a-45a2-4d34-96f6-dedb574cb508 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| 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 |
| 17856-0640 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate, Acetaminophen |
| 64376-640 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate, Acetaminophen |
| 54348-066 | HYDROCODONE/APAP | HYDROCODONE BITARTRATE, ACETAMINOPHEN |