HYDROCODONE /APAP is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Hydrocodone Bitartrate; Acetaminophen.
| Product ID | 61919-618_86325900-d618-f02b-e053-2991aa0a8e99 |
| NDC | 61919-618 |
| Product Type | Human Prescription Drug |
| Proprietary Name | HYDROCODONE /APAP |
| Generic Name | Hydrocodone /apap |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-04-10 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA201013 |
| Labeler Name | DIRECTRX |
| 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 | 2019-04-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-17 |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-22 |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-22 |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-17 |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-04-10 |
| Marketing Category | ANDA |
| Application Number | ANDA201013 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-06-05 |
| Ingredient | Strength |
|---|---|
| HYDROCODONE BITARTRATE | 5 mg/1 |
| SPL SET ID: | 86325900-d617-f02b-e053-2991aa0a8e99 |
| Manufacturer | |
| UNII |