Prescription drug · ANDA
Butalbital, Acetaminophen and Caffeine NDC 60760-865
Butalbital 50 mg/1 + 2 more ingredients · Tablet · Oral · ST. MARY'S MEDICAL PARK PHARMACY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60760-865-12 | 6076008651260760086512 | 12 TABLET in 1 BOTTLE, PLASTIC (60760-865-12)Marketed from May 19, 2025 |
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
- Tablet
- Route
- Oral
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACYNDC labeler code 60760
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040864
- 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 60760-865_36229f4e-5921-2fcd-e063-6294a90af60dSPL ID 36229f4e-5921-2fcd-e063-6294a90af60dSPL set ID 36229f70-aa73-b112-e063-6394a90a5b49RxCUI 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
N460760086512followed by a unit qualifier and the quantityPackage 60760-0865-12. 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 butalbital, acetaminophen, and caffeine tablets 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 60760-865
- What is NDC 60760-865?
- 60760-865 is the product NDC for Butalbital, Acetaminophen and Caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by ST. MARY'S MEDICAL PARK PHARMACY. 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?
- ST. MARY'S MEDICAL PARK PHARMACY, NDC labeler code 60760. 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 040864
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 | Golden State Medical Supply, Inc. | 51407-556 |
| Butalbital, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Granules Pharmaceuticals Inc. | 70010-149 |
| Butalbital, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Bryant Ranch Prepack | 71335-2270 |
| Butalbital, Acetaminophen and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Bryant Ranch Prepack | 71335-2272 |