Prescription drug · ANDA
Butalbital, Acetaminophen and Caffeine NDC 13107-075
Butalbital 50 mg/1 + 2 more ingredients · Capsule · Oral · Aurolife Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-075-01 | 1310700750113107007501 | 100 CAPSULE in 1 BOTTLE (13107-075-01)Marketed from Apr 26, 2017 | |
| 13107-075-05 | 1310700750513107007505 | 500 CAPSULE in 1 BOTTLE (13107-075-05)Marketed from Apr 26, 2017 | |
| 13107-075-30 | 1310700753013107007530 | 30 CAPSULE in 1 BOTTLE (13107-075-30)Marketed from Apr 26, 2017 |
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
- Capsule
- Route
- Oral
- Labeler
- Aurolife Pharma, LLCNDC labeler code 13107
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204733
- 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 13107-075_bc2de4b3-7c0d-48db-b6e1-ee41bfad08e5SPL ID bc2de4b3-7c0d-48db-b6e1-ee41bfad08e5SPL set ID f9fde75d-7def-48fc-a2b0-727f677f6001RxCUI 238153UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338EUPC 0313107075308
- 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
N413107007501followed by a unit qualifier and the quantityPackage 13107-0075-01. 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 13107-075
- What is NDC 13107-075?
- 13107-075 is the product NDC for Butalbital, Acetaminophen and Caffeine, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Aurolife Pharma, LLC. It has 3 package NDCs, 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?
- Aurolife Pharma, LLC, NDC labeler code 13107. 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 |