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NDC 35573-0455-02 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 TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Burel Pharmaceuticals, LLC. The primary component is ACETAMINOPHEN; BUTALBITAL.
Product Information
| NDC | 35573-0455 |
|---|---|
| Product ID | 35573-455_877b0e9f-f7c3-40a9-905d-eb1c9eaec4e6 |
| Associated GPIs | |
| GCN Sequence Number | 068779 |
| GCN Sequence Number Description | butalbital/acetaminophen TABLET 50MG-300MG ORAL |
| HIC3 | H3K |
| HIC3 Description | ANALGESIC, NON-SALICYLATE AND BARBITURATE COMBINAT |
| GCN | 31623 |
| 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 | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 300; 50 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; BUTALBITAL |
| Labeler Name | Burel Pharmaceuticals, LLC |
| Pharmaceutical Class | Barbiturate [EPC], Barbiturates [CS] |
| DEA Schedule | CIII |
| Marketing Category | ANDA |
| Application Number | ANDA214088 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 35573-0455-02 (35573045502)
| NDC Package Code | 35573-455-02 |
|---|---|
| Billing NDC | 35573045502 |
| Package | 100 TABLET in 1 BOTTLE (35573-455-02) |
| Marketing Start Date | 2022-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |