HYDROCODONE BIT/APAP is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Hydrocodone Bitartrate; Acetaminophen.
| Product ID | 45865-411_1e13cbb2-936a-4919-e054-00144ff8d46c |
| NDC | 45865-411 |
| Product Type | Human Prescription Drug |
| Proprietary Name | HYDROCODONE BIT/APAP |
| Generic Name | Hydrocodone Bitartrate And Acetaminophen |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-07-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA040400 |
| Labeler Name | Medsource Pharmaceuticals |
| Substance Name | HYDROCODONE BITARTRATE; ACETAMINOPHEN |
| Active Ingredient Strength | 10 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 | 2011-07-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040400 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-07-01 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| HYDROCODONE BITARTRATE | 10 mg/1 |
| SPL SET ID: | 53b3ed76-db40-4aa8-8c55-21991d557b42 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 45865-411 | HYDROCODONE BIT/APAP | HYDROCODONE BIT/APAP |
| 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 |
| 0023-6002 | Norco | Hydrocodone Bitartrate and Acetaminophen |
| 0023-6021 | Norco | Hydrocodone Bitartrate and Acetaminophen |
| 0023-6022 | Norco | Hydrocodone Bitartrate and Acetaminophen |
| 0074-3041 | Vicodin | Hydrocodone Bitartrate and Acetaminophen |
| 0074-3043 | Vicodin | Hydrocodone Bitartrate and Acetaminophen |
| 0074-3054 | Vicodin | Hydrocodone Bitartrate and Acetaminophen |
| 0121-1542 | Zamicet | HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| 0121-2313 | Zamicet | HYDROCODONE BITARTRATE and ACETAMINOPHEN |