Prescription drug · ANDA
butalbital, aspirin, and caffeine NDC 62135-433
Butalbital 50 mg/1 + 2 more ingredients · Capsule · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-433-90 | 62135043390 | 90 CAPSULE in 1 BOTTLE (62135-433-90)Marketed from Dec 12, 2022 |
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)
- butalbital, aspirin, and caffeine
- Generic name (nonproprietary)
- butalbital, aspirin, and caffeine
- Active ingredients
- Butalbital — 50 mg/1Aspirin — 325 mg/1Caffeine — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086996
- 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)Xanthines (Chemical structure)
- Identifiers
- Product ID 62135-433_5a7120cb-2df4-1ee8-e063-6394a90acd6cSPL ID 5a7120cb-2df4-1ee8-e063-6394a90acd6cSPL set ID e69d8bb1-ba09-42e2-8372-7f5e0a906174RxCUI 238134UNII KHS0AZ4JVK, R16CO5Y76E, 3G6A5W338EUPC 0362135433901
- Pharmacologic class
- Barbiturate; Central Nervous System Stimulant; Methylxanthine; Nonsteroidal Anti-inflammatory Drug; 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
N462135043390followed by a unit qualifier and the quantityPackage 62135-0433-90. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Butalbital, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine capsules in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Excerpt only. Read the full label for complete information.
About NDC 62135-433
- What is NDC 62135-433?
- 62135-433 is the product NDC for butalbital, aspirin, and caffeine, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- butalbital, aspirin, and caffeine.
- What is the active ingredient?
- Butalbital, Aspirin, Caffeine.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. 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, and caffeine?
- 4 other product NDCs are listed under this name. See all butalbital, aspirin, and caffeine 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, and caffeine 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, And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-416 | 69367-0416-01 |
| Butalbital, aspirin, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Sandoz Inc | 0781-2270 | 00781-2270-01 |
| Butalbital, Aspirin, and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | LGM PHARMA SOLUTIONS, LLC | 79739-7192 | 79739-7192-0179739-7192-05 |
| Butalbital, aspirin, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Lannett Company, Inc. | 0527-1552 | 00527-1552-01 |
Other NDCs under ANDA 086996
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, aspirin, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Lannett Company, Inc. | 0527-1552 |
| Butalbital, aspirin, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Sandoz Inc | 0781-2270 |