Prescription drug · NDA AUTHORIZED GENERIC
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate NDC 0591-3220
Codeine phosphate 30 mg/1 + 3 more ingredients · Capsule · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-3220-01 | 00591322001 | 100 CAPSULE in 1 BOTTLE (0591-3220-01)Marketed from Sep 18, 2003 |
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
- Codeine phosphate — 30 mg/1Butalbital — 50 mg/1Caffeine — 40 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020232
- 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 0591-3220_519e2ce9-e4af-4bd7-96fd-8bee4e3b4537SPL ID 519e2ce9-e4af-4bd7-96fd-8bee4e3b4537SPL set ID a58819b8-a52c-44a7-9ab0-c74480d98506RxCUI 993943UNII GSL05Y1MN6, KHS0AZ4JVK, 3G6A5W338E, 362O9ITL9D
- 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
N400591322001followed by a unit qualifier and the quantityPackage 00591-3220-01. 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, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions ( 5.1 )], reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficien…
Excerpt only. Read the full label for complete information.
- openFDA data updated
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