Prescription drug · ANDA
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE NDC 69238-1993
Butalbital 50 mg/1 + 3 more ingredients · Capsule · Oral · Amneal Pharmaceuticals of New York, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1993-1 | 69238199301 | 100 CAPSULE in 1 BOTTLE (69238-1993-1)Marketed from Apr 1, 2019 |
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
- Amneal Pharmaceuticals of New York, LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074951
- 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 69238-1993_f3869a7a-b5f3-4279-b07b-ff01a8c2a286SPL ID f3869a7a-b5f3-4279-b07b-ff01a8c2a286SPL set ID 828e30fa-7bb1-486b-80ee-806fce45e4e4RxCUI 994237UNII KHS0AZ4JVK, R16CO5Y76E, 3G6A5W338E, GSL05Y1MN6UPC 0369238199314
- 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
N469238199301followed by a unit qualifier and the quantityPackage 69238-1993-01. 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, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE 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, misuse, overdose, and…
Excerpt only. Read the full label for complete information.
About NDC 69238-1993
- What is NDC 69238-1993?
- 69238-1993 is the product NDC for BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE, Butalbital 50 mg/1 + 3 more ingredients capsule, listed with the FDA by Amneal Pharmaceuticals of New York, LLC. It has 1 package NDC, 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?
- Amneal Pharmaceuticals of New York, LLC, NDC labeler code 69238. 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 | Bryant Ranch Prepack | 63629-2952 | 63629-2952-0163629-2952-0263629-2952-03+3 more |