NDC product
BUTALBITAL AND ACETAMINOPHEN
NDC 35573-455 · Burel Pharmaceuticals, LLC
Key facts
| Product NDC | 35573-455 |
|---|---|
| Proprietary name | BUTALBITAL AND ACETAMINOPHEN |
| Nonproprietary name | butalbital and acetaminophen |
| Substances | BUTALBITAL, ACETAMINOPHEN |
| Dosage form | TABLET |
| Route | ORAL |
| Labeler | Burel Pharmaceuticals, LLC |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Application number | ANDA214088 |
| DEA schedule | CIII |
| Pharmacologic classes | Barbiturate [EPC], Barbiturates [CS] |
| Marketing start | Dec 1, 2022 |
| Listing certified through | Dec 31, 2026 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: