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NDC 00121-0504-00 Acetaminophen and Codeine Phosphate 120; 12 mg/5mL; mg/5mL Details
Acetaminophen and Codeine Phosphate 120; 12 mg/5mL; mg/5mL
Acetaminophen and Codeine Phosphate is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PAI Holdings, LLC. The primary component is ACETAMINOPHEN; CODEINE PHOSPHATE.
MedlinePlus Drug Summary
The combination of acetaminophen and codeine is used to relieve mild to moderate pain. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing.
Related Packages: 00121-0504-00Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Acetaminophen and Codeine
Product Information
| NDC | 00121-0504 |
|---|---|
| Product ID | 0121-0504_6514a566-da45-4e96-a5f7-13aaf8246401 |
| Associated GPIs | 65991002052020 |
| GCN Sequence Number | 070212 |
| GCN Sequence Number Description | acetaminophen with codeine SOLUTION 120-12MG/5 ORAL |
| HIC3 | H3U |
| HIC3 Description | OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS |
| GCN | 33589 |
| HICL Sequence Number | 001717 |
| HICL Sequence Number Description | ACETAMINOPHEN WITH CODEINE PHOSPHATE |
| Brand/Generic | Generic |
| Proprietary Name | Acetaminophen and Codeine Phosphate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN and CODEINE PHOSPHATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 120; 12 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE |
| Labeler Name | PAI Holdings, LLC |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CV |
| Marketing Category | ANDA |
| Application Number | ANDA087508 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00121-0504-00 (00121050400)
| NDC Package Code | 0121-0504-00 |
|---|---|
| Billing NDC | 00121050400 |
| Package | 10 TRAY in 1 CASE (0121-0504-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0504-05) |
| Marketing Start Date | 1981-08-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |