butalbital, aspirin, and caffeine
- Product NDC
- 62135-433
- 11-digit product format
- 621350433
- Labeler code
- 62135
- Product ID
- 62135-433_458c094e-5759-0b4a-e063-6394a90aa3f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital, aspirin, and caffeine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA086996
- Marketing category
- ANDA
- Marketing start
- 1985-10-11
- Substance
- ASPIRIN; BUTALBITAL; CAFFEINE
- Active strength
- 325; 50; 40 mg/1; mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- butalbital, aspirin, and caffeine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ASPIRIN | 325 mg/1 |
| BUTALBITAL | 50 mg/1 |
| CAFFEINE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R16CO5Y76E, KHS0AZ4JVK, 3G6A5W338E |
| Rxcui | 238134 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-433-90 | butalbital, aspirin, and caffeine | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-433 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [CHARTWELL RX, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231004_e69d8bb1-ba09-42e2-8372-7f5e0a906174.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62135-433-90 | 62135043390 | 90 CAPSULE in 1 BOTTLE (62135-433-90) | 90 capsule | 2022-12-12 | 0000-00-00 | No | No | Current |