Prescription drug · ANDA
Butalbital, Acetaminophen, and Caffeine NDC 42291-181
Butalbital 50 mg/1 + 2 more ingredients · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-181-01 | 4229101810142291018101 | 100 CAPSULE in 1 BOTTLE (42291-181-01)Marketed from Nov 24, 2014 |
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 — 300 mg/1Caffeine — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040885
- 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 42291-181_43545fa6-9313-8af9-e063-6294a90af617SPL ID 43545fa6-9313-8af9-e063-6294a90af617SPL set ID f5bbad36-6a0e-3518-3f12-138ae9f63980RxCUI 889520UNII 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
N442291018101followed by a unit qualifier and the quantityPackage 42291-0181-01. 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 Capsules, USP 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 42291-181
- What is NDC 42291-181?
- 42291-181 is the product NDC for Butalbital, Acetaminophen, and Caffeine, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Butalbital, Acetaminophen, and Caffeine.
- What is the active ingredient?
- Butalbital, Acetaminophen, Caffeine.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. 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, Acetaminophen, and Caffeine?
- 50 other product NDCs are listed under this name. See all Butalbital, Acetaminophen, and Caffeine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Butalbital, Acetaminophen, and Caffeine 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, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4126 | 68788-4126-0268788-4126-03 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | REMEDYREPACK INC. | 70518-4601 | 70518-4601-0070518-4601-0170518-4601-02 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Amici Pharma, Inc. | 69292-305 | 69292-0305-01 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0567 | 80425-0567-0180425-0567-0280425-0567-03 |
| Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/15mL + 2 more ingredients | SolutionOral | Genus Lifesciences Inc. | 64950-290 | 64950-0290-16 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0497 | 80425-0497-01 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8794 | 68788-8794-0268788-8794-03 |
| butalbital, acetaminophen and caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Dr. Reddy's Labratories Inc. | 75907-009 | 75907-0009-01 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | QUAGEN PHARMACEUTICALS LLC | 70752-142 | 70752-0142-1070752-0142-14 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | QUAGEN PHARMACEUTICALS LLC | 70752-144 | 70752-0144-1070752-0144-14 |
Other NDCs under ANDA 040885
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 | CapsuleOral | Actavis Pharma, Inc. | 0591-2640 |
| Fioricetbutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Actavis Pharma, Inc. | 52544-080 |