Product NDC: | 43063-355 |
Proprietary Name: | Hydrocodone Bitartrate And Acetaminophen |
Non Proprietary Name: | Hydrocodone Bitartrate And Acetaminophen |
Active Ingredient(s): | 500; 5 mg/1; mg/1 & nbsp; Hydrocodone Bitartrate And Acetaminophen |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 43063-355 |
Labeler Name: | PD-Rx Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA089971 |
Marketing Category: | ANDA |
Start Marketing Date: | 19881202 |
Package NDC: | 43063-355-98 |
Package Description: | 120 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-98) > 90 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-90) > 60 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-60) > 40 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-40) > 30 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-30) > 25 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-25) > 24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-24) > 20 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-20) > 18 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-18) > 15 BOTTLE, SPRAY in 1 BOTTLE, PLASTIC (43063-355-15) > 12 BOTTLE, PLASTIC in 1 BOTTLE, SPRAY (43063-355-12) > 10 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-10) > 6 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-06) > 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-04) > 3 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-03) > 2 TABLET in 1 BOTTLE, PLASTIC (43063-355-02) |
NDC Code | 43063-355-98 |
Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
Package Description | 120 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-98) > 90 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-90) > 60 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-60) > 40 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-40) > 30 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-30) > 25 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-25) > 24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-24) > 20 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-20) > 18 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-18) > 15 BOTTLE, SPRAY in 1 BOTTLE, PLASTIC (43063-355-15) > 12 BOTTLE, PLASTIC in 1 BOTTLE, SPRAY (43063-355-12) > 10 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-10) > 6 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-06) > 4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-04) > 3 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (43063-355-03) > 2 TABLET in 1 BOTTLE, PLASTIC (43063-355-02) |
Product NDC | 43063-355 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 19881202 |
Marketing Category Name | ANDA |
Labeler Name | PD-Rx Pharmaceuticals, Inc. |
Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Strength Number | 500; 5 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |