Prescription drug · ANDA
Ascomp with Codeine NDC 51991-074
butalbital, aspirin, caffeine and codeine phosphate · Butalbital 50 mg/1 + 3 more ingredients · Capsule · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-074-01 | 51991007401 | 100 CAPSULE in 1 BOTTLE, PLASTIC (51991-074-01)Marketed from May 1, 2009 | |
| 51991-074-05 | 51991007405 | 500 CAPSULE in 1 BOTTLE, PLASTIC (51991-074-05)Marketed from May 1, 2009 |
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)
- Ascomp with Codeine
- Generic name (nonproprietary)
- butalbital, aspirin, caffeine and codeine phosphate
- Active ingredients
- Butalbital — 50 mg/1Aspirin — 325 mg/1Caffeine — 40 mg/1Codeine phosphate — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075231
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Non-Steroidal (Chemical structure)Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Cyclooxygenase Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)Decreased Prostaglandin Production (Physiologic effect)Full Opioid Agonists (Mechanism)Xanthines (Chemical structure)
- Identifiers
- Product ID 51991-074_a41a61f0-e530-4fb5-8198-bdc866219e33SPL ID a41a61f0-e530-4fb5-8198-bdc866219e33SPL set ID 243a6aea-0f48-42a9-a85e-ff247ab94336RxCUI 994237, 994239UNII KHS0AZ4JVK, R16CO5Y76E, 3G6A5W338E, GSL05Y1MN6
- Pharmacologic class
- Barbiturate; Central Nervous System Stimulant; Methylxanthine; Nonsteroidal Anti-inflammatory Drug; Opioid Agonist; Platelet Aggregation Inhibitor
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
N451991007401followed by a unit qualifier and the quantityPackage 51991-0074-01. 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)
ASCOMP with Codeine is 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 ASCOMP with Codeine, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ASCOMP with Codeine should not be used for an extended period of time unles…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075231
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 |
|---|---|---|---|---|
| Ascomp with Codeinebutalbital, aspirin, cafeine, and codeine phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | LGM PHARMA SOLUTIONS, LLC | 79739-6094 |
| Butalbital, Aspirin, Caffeine And Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Bryant Ranch Prepack | 63629-2952 |