Prescription drug · ANDA
Butalbital And Acetaminophen NDC 35573-455
Butalbital 50 mg/1; Acetaminophen 300 mg/1 · Tablet · Oral · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-455-02 | 3557304550235573045502 | 100 TABLET in 1 BOTTLE (35573-455-02)Marketed from Dec 1, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Butalbital And Acetaminophen
- Generic name (nonproprietary)
- butalbital and acetaminophen
- Active ingredients
- Butalbital — 50 mg/1Acetaminophen — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Burel Pharmaceuticals, LLCNDC labeler code 35573
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214088
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Barbiturates (Chemical structure)
- Identifiers
- Product ID 35573-455_f989ac8c-abbb-4bd1-8680-f7177b06f60eSPL ID f989ac8c-abbb-4bd1-8680-f7177b06f60eSPL set ID 0a8a6a16-b23f-45d2-b5d4-540264e74d14RxCUI 197426, 1249617UNII 362O9ITL9D, KHS0AZ4JVKUPC 0335573455026, 0335573456023
- Pharmacologic class
- Barbiturate
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N435573045502followed by a unit qualifier and the quantityPackage 35573-0455-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Butalbital and acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Excerpt only. Read the full label for complete information.
About NDC 35573-455
- What is NDC 35573-455?
- 35573-455 is the product NDC for Butalbital And Acetaminophen, Butalbital 50 mg/1; Acetaminophen 300 mg/1 tablet, listed with the FDA by Burel Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Butalbital And Acetaminophen.
- What is the active ingredient?
- Butalbital, Acetaminophen.
- Who is the labeler?
- Burel Pharmaceuticals, LLC, NDC labeler code 35573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Butalbital And Acetaminophen?
- 13 other product NDCs are listed under this name. See all Butalbital And Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Butalbital And Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Butalbital And Acetaminophen | Acetaminophen 300 mg/1; Butalbital 50 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-301 | 69292-0301-01 |
| Butalbital And Acetaminophen | Acetaminophen 325 mg/1; Butalbital 50 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-302 | 69292-0302-01 |
| Butalbital And Acetaminophen | Acetaminophen 325 mg/1; Butalbital 25 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-303 | 69292-0303-01 |
| Butalbital And Acetaminophen | Acetaminophen 300 mg/1; Butalbital 50 mg/1 | TabletOral | Aarkish Pharmaceuticals NJ Inc. | 81005-123 | 81005-0123-01 |
| butalbital and acetaminophen | Butalbital 50 mg/1; Acetaminophen 300 mg/1 | CapsuleOral | Dr. Reddy's Labratories Inc. | 75907-008 | 75907-0008-01 |
| BUTALBITAL and ACETAMINOPHEN | Butalbital 50 mg/1; Acetaminophen 300 mg/1 | TabletOral | QUAGEN PHARMACEUTICALS LLC | 70752-147 | 70752-0147-1070752-0147-14 |
| BUTALBITAL and ACETAMINOPHEN | Butalbital 50 mg/1; Acetaminophen 325 mg/1 | TabletOral | QUAGEN PHARMACEUTICALS LLC | 70752-148 | 70752-0148-1070752-0148-14 |
| Butalbital And Acetaminophen | Butalbital 50 mg/1; Acetaminophen 325 mg/1 | TabletOral | Burel Pharmaceuticals, LLC | 35573-456 | 35573-0456-02 |
| butalbital and acetaminophen | Butalbital 50 mg/1; Acetaminophen 300 mg/1 | CapsuleOral | Granules Pharmaceuticals Inc. | 70010-054 | 70010-0054-0170010-0054-05 |
| Butalbital and Acetaminophenbutalbital and acetaminophen tablets | Butalbital 50 mg/1; Acetaminophen 300 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-306 | 68682-0306-01 |
Other NDCs under ANDA 214088
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Butalbital And Acetaminophen | Butalbital 50 mg/1; Acetaminophen 325 mg/1 | TabletOral | Burel Pharmaceuticals, LLC | 35573-456 |
| Butalbital And Acetaminophen | Acetaminophen 300 mg/1; Butalbital 50 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-301 |
| Butalbital And Acetaminophen | Acetaminophen 325 mg/1; Butalbital 50 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-302 |
| Butalbital And Acetaminophen | Acetaminophen 325 mg/1; Butalbital 25 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-303 |