Prescription drug · ANDA
Butalbital, Acetaminophen, Caffeine NDC 50268-553
butalbital, acetaminophen, and caffeine · Butalbital 50 mg/1 + 2 more ingredients · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-553-13 | 50268055313 | 30 BLISTER PACK in 1 BOX (50268-553-13) / 1 TABLET in 1 BLISTER PACK (50268-553-11)Marketed from Aug 11, 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, 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
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209587
- 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 50268-553_2b4a7d93-e919-27be-e063-6294a90a1db0SPL ID 2b4a7d93-e919-27be-e063-6294a90a1db0SPL set ID e5fbd6b8-85e7-8847-e053-2a95a90a52edRxCUI 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
N450268055313followed by a unit qualifier and the quantityPackage 50268-0553-13. 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 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.
Other NDCs under ANDA 209587
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, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | A-S Medication Solutions | 50090-7042 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | REMEDYREPACK INC. | 70518-4309 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Proficient Rx LP | 71205-981 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0570 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Asclemed USA, Inc. | 76420-802 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8137 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Proficient Rx LP | 71205-510 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Westminster Pharmaceuticals, LLC | 69367-203 |
| Butalbital, Acetaminophen, and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | LGM PHARMA SOLUTIONS, LLC | 79739-7320 |
| Butal/Apap/Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Direct_Rx | 72189-600 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | HAWAII REPACK, INC. | 85534-0046 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Bryant Ranch Prepack | 71335-1764 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Bryant Ranch Prepack | 71335-1767 |