Prescription drug · ANDA
Butalbital, Aspirin, Caffeine And Codeine Phosphate NDC 63629-2952
Butalbital 50 mg/1 + 3 more ingredients · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2952-1 | 6362929520163629295201 | 30 CAPSULE in 1 BOTTLE (63629-2952-1)Marketed from Dec 22, 2021 | |
| 63629-2952-2 | 6362929520263629295202 | 20 CAPSULE in 1 BOTTLE (63629-2952-2)Marketed from Dec 22, 2021 | |
| 63629-2952-3 | 6362929520363629295203 | 90 CAPSULE in 1 BOTTLE (63629-2952-3)Marketed from Mar 30, 2010 | |
| 63629-2952-4 | 6362929520463629295204 | 60 CAPSULE in 1 BOTTLE (63629-2952-4)Marketed from Mar 30, 2010 | |
| 63629-2952-5 | 6362929520563629295205 | 40 CAPSULE in 1 BOTTLE (63629-2952-5)Marketed from Sep 26, 2014 | |
| 63629-2952-6 | 6362929520663629295206 | 18 CAPSULE in 1 BOTTLE (63629-2952-6)Marketed from Dec 22, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Aspirin, Caffeine And Codeine Phosphate
- 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
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-2952_65596803-c8a0-47a5-b76a-e24e03cb5b85SPL ID 65596803-c8a0-47a5-b76a-e24e03cb5b85SPL set ID 95a33c9b-79a6-47c7-8433-fc217950b88fRxCUI 994237UNII 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
N463629295201followed by a unit qualifier and the quantityPackage 63629-2952-01. 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. ASCOMP with Codeine is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, caffeine, a methylxanthine, and codeine phosphate, an opioid agonist, and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesics and alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids and butalbital, which can occur at any dosage or duration, r…
Excerpt only. Read the full label for complete information.
About NDC 63629-2952
- What is NDC 63629-2952?
- 63629-2952 is the product NDC for Butalbital, Aspirin, Caffeine And Codeine Phosphate, Butalbital 50 mg/1 + 3 more ingredients capsule, listed with the FDA by Bryant Ranch Prepack. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Butalbital, Aspirin, Caffeine And Codeine Phosphate.
- What is the active ingredient?
- Butalbital, Aspirin, Caffeine, Codeine phosphate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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, Aspirin, Caffeine And Codeine Phosphate?
- 1 other product NDC are listed under this name. See all Butalbital, Aspirin, 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, Aspirin, 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, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Amneal Pharmaceuticals of New York, LLC | 69238-1993 | 69238-1993-01 |
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, caffeine and codeine phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-074 |
| Ascomp with Codeinebutalbital, aspirin, cafeine, and codeine phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | LGM PHARMA SOLUTIONS, LLC | 79739-6094 |