Prescription drug · ANDA
Butalbital, Acetaminophen and Caffeine NDC 71335-9603
Butalbital 50 mg/1 + 2 more ingredients · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9603-0 | 71335960300 | 84 TABLET in 1 BOTTLE (71335-9603-0)Marketed from Dec 7, 2022 | |
| 71335-9603-1 | 71335960301 | 20 TABLET in 1 BOTTLE (71335-9603-1)Marketed from Feb 14, 2023 | |
| 71335-9603-2 | 71335960302 | 30 TABLET in 1 BOTTLE (71335-9603-2)Marketed from Dec 7, 2022 | |
| 71335-9603-3 | 71335960303 | 60 TABLET in 1 BOTTLE (71335-9603-3)Marketed from Apr 3, 2024 | |
| 71335-9603-4 | 71335960304 | 90 TABLET in 1 BOTTLE (71335-9603-4)Marketed from Apr 3, 2024 | |
| 71335-9603-5 | 71335960305 | 50 TABLET in 1 BOTTLE (71335-9603-5)Marketed from Apr 3, 2024 | |
| 71335-9603-6 | 71335960306 | 6 TABLET in 1 BOTTLE (71335-9603-6)Marketed from Apr 3, 2024 | |
| 71335-9603-7 | 71335960307 | 120 TABLET in 1 BOTTLE (71335-9603-7)Marketed from Apr 3, 2024 | |
| 71335-9603-8 | 71335960308 | 40 TABLET in 1 BOTTLE (71335-9603-8)Marketed from Apr 3, 2024 | |
| 71335-9603-9 | 71335960309 | 12 TABLET in 1 BOTTLE (71335-9603-9)Marketed from Apr 3, 2024 |
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 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
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211106
- 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 71335-9603_9cd0d6ab-cb53-47bd-9417-0ad88c4571a4SPL ID 9cd0d6ab-cb53-47bd-9417-0ad88c4571a4SPL set ID e9dffed5-d615-4e63-9860-c0f6f23848a1RxCUI 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
N471335960300followed by a unit qualifier and the quantityPackage 71335-9603-00. 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 211106
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 | KVK-Tech, Inc. | 10702-253 |
| Butalbital, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Redpharm Drug | 67296-2204 |
| Butalbital, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | A-S Medication Solutions | 50090-7519 |
| Butalbital, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4126 |