Prescription drug · ANDA
Butalbital, Acetaminophen and Caffeine NDC 51407-556
Butalbital 50 mg/1 + 2 more ingredients · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-556-01 | 51407055601 | 100 TABLET in 1 BOTTLE (51407-556-01)Marketed from Sep 12, 2022 | |
| 51407-556-05 | 51407055605 | 500 TABLET in 1 BOTTLE (51407-556-05)Marketed from Nov 22, 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, Acetaminophen and Caffeine
- Generic name (nonproprietary)
- butalbital, acetaminophen and caffeine
- Active ingredients
- Butalbital — 50 mg/1Acetaminophen — 325 mg/1Caffeine — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040864
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
- Identifiers
- Product ID 51407-556_f707fd82-6f8c-d43a-e053-6394a90a1012SPL ID f707fd82-6f8c-d43a-e053-6394a90a1012SPL set ID ee131bce-863b-b5a1-e053-2a95a90afc79RxCUI 238154UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338E
- Pharmacologic class
- Barbiturate; Central Nervous System Stimulant; Methylxanthine
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
N451407055601followed by a unit qualifier and the quantityPackage 51407-0556-01. 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, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, acetaminophen, and caffeine tablets 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.
Other NDCs under ANDA 040864
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, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Granules Pharmaceuticals Inc. | 70010-149 |
| Butalbital, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-865 |
| Butalbital, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Bryant Ranch Prepack | 71335-2270 |
| Butalbital, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Bryant Ranch Prepack | 71335-2272 |