Prescription drug · ANDA
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate NDC 0591-2641
Butalbital 50 mg/1 + 3 more ingredients · Capsule · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-2641-01 | 0059126410100591264101 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2641-01)Marketed from Jul 29, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Caffeine, and Codeine Phosphate
- Generic name (nonproprietary)
- butalbital, acetaminophen, caffeine, and codeine phosphate
- Active ingredients
- Butalbital — 50 mg/1Acetaminophen — 300 mg/1Caffeine — 40 mg/1Codeine phosphate — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076560
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Full Opioid Agonists (Mechanism)Xanthines (Chemical structure)
- Identifiers
- Product ID 0591-2641_423a1275-8347-42e4-82b9-bd4f193c03e6SPL ID 423a1275-8347-42e4-82b9-bd4f193c03e6SPL set ID 52321fe5-c001-4e2d-8149-3197ddc13764RxCUI 1431286UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338E, GSL05Y1MN6
- Pharmacologic class
- Barbiturate; Central Nervous System Stimulant; Methylxanthine; Opioid Agonist
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
N400591264101followed by a unit qualifier and the quantityPackage 00591-2641-01. 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)
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions ( 5.1 )], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia or are not exp…
Excerpt only. Read the full label for complete information.
About NDC 0591-2641
- What is NDC 0591-2641?
- 0591-2641 is the product NDC for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate, Butalbital 50 mg/1 + 3 more ingredients capsule, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate.
- What is the active ingredient?
- Butalbital, Acetaminophen, Caffeine, Codeine phosphate.
- Who is the labeler?
- Actavis Pharma, Inc., NDC labeler code 0591. 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, Caffeine, and Codeine Phosphate?
- 7 other product NDCs are listed under this name. See all Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate 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, Caffeine, and Codeine Phosphate 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, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0650 | 00054-0650-25 |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-3000 | 00054-3000-01 |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-073 | 51991-0073-01 |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Bryant Ranch Prepack | 71335-0194 | 71335-0194-0171335-0194-0271335-0194-03+4 more |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Bryant Ranch Prepack | 72162-1591 | 72162-1591-02 |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | LGM PHARMA SOLUTIONS, LLC | 79739-6670 | 79739-6670-0179739-6670-05 |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Codeine phosphate 30 mg/1 + 3 more ingredients | CapsuleOral | Actavis Pharma, Inc. | 0591-3220 | 00591-3220-01 |
Other NDCs under ANDA 076560
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, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-073 |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Bryant Ranch Prepack | 71335-0194 |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Bryant Ranch Prepack | 72162-1591 |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | LGM PHARMA SOLUTIONS, LLC | 79739-6670 |