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NDC 68382-0334-05 Tramadol Hydrochloride and Acetaminophen 325; 37.5 mg/1; mg/1 Details
Tramadol Hydrochloride and Acetaminophen 325; 37.5 mg/1; mg/1
Tramadol Hydrochloride and Acetaminophen is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). 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.
Related Packages: 68382-0334-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Tramadol is used to relieve moderate to moderately severe pain. Tramadol extended-release tablets and capsules are only used by people who are expected to need medication to relieve pain around-the-clock. Tramadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Related Packages: 68382-0334-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tramadol
Product Information
| NDC | 68382-0334 |
|---|---|
| Product ID | 68382-334_3acb87d9-5a97-427a-a9f2-d1f158f60337 |
| Associated GPIs | 65995002200320 |
| GCN Sequence Number | 048456 |
| GCN Sequence Number Description | tramadol HCl/acetaminophen TABLET 37.5-325MG ORAL |
| HIC3 | H3U |
| HIC3 Description | OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS |
| GCN | 13909 |
| HICL Sequence Number | 022880 |
| HICL Sequence Number Description | TRAMADOL HCL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Tramadol Hydrochloride and Acetaminophen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tramadol Hydrochloride and Acetaminophen |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 325; 37.5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA090460 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0334-05 (68382033405)
| NDC Package Code | 68382-334-05 |
|---|---|
| Billing NDC | 68382033405 |
| Package | 500 TABLET, FILM COATED in 1 BOTTLE (68382-334-05) |
| Marketing Start Date | 2012-10-15 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.11778 |
| Pricing Unit | EA |
| Effective Date | 2022-08-17 |
| NDC Description | TRAMADOL-ACETAMINOPHEN 37.5-325 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2022-08-31 |