Prescription drug · ANDA
Butalbital, Acetaminophen, Caffeine NDC 70518-4309
butalbital, acetaminophen, and caffeine · Butalbital 50 mg/1 + 2 more ingredients · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4309-0 | 70518430900 | 100 TABLET in 1 BOTTLE, PLASTIC (70518-4309-0)Marketed from Mar 14, 2025 | |
| 70518-4309-1 | 70518430901 | 60 TABLET in 1 BOTTLE, PLASTIC (70518-4309-1)Marketed from Aug 4, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.
- 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 70518-4309_5a99bd98-6741-2a2f-e063-6394a90a0229SPL ID 5a99bd98-6741-2a2f-e063-6394a90a0229SPL set ID dc2bb7fc-1722-4865-a02c-be5e5c211505RxCUI 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
N470518430900followed by a unit qualifier and the quantityPackage 70518-4309-00. 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 | AvPAK | 50268-553 |
| 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 |