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NDC 51862-0544-01 butalbital and acetaminophen 300; 50 mg/1; mg/1 Details
butalbital and acetaminophen 300; 50 mg/1; mg/1
butalbital and acetaminophen is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mayne Pharma. The primary component is ACETAMINOPHEN; BUTALBITAL.
Product Information
| NDC | 51862-0544 |
|---|---|
| Product ID | 51862-544_0e8544ff-f3e3-f505-e063-6394a90a81d5 |
| Associated GPIs | 64991002120105 |
| GCN Sequence Number | 078660 |
| GCN Sequence Number Description | butalbital/acetaminophen CAPSULE 50MG-300MG ORAL |
| HIC3 | H3K |
| HIC3 Description | ANALGESIC, NON-SALICYLATE AND BARBITURATE COMBINAT |
| GCN | 45029 |
| HICL Sequence Number | 001858 |
| HICL Sequence Number Description | BUTALBITAL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | butalbital and acetaminophen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | butalbital and acetaminophen |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 300; 50 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; BUTALBITAL |
| Labeler Name | Mayne Pharma |
| Pharmaceutical Class | Barbiturate [EPC], Barbiturates [CS] |
| DEA Schedule | CIII |
| Marketing Category | ANDA |
| Application Number | ANDA207313 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 51862-0544-01 (51862054401)
| NDC Package Code | 51862-544-01 |
|---|---|
| Billing NDC | 51862054401 |
| Package | 100 CAPSULE in 1 BOTTLE (51862-544-01) |
| Marketing Start Date | 2018-07-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |