Butalbital, aspirin, and caffeine
- Product NDC
- 0781-2270
- 11-digit product format
- 007812270
- Labeler code
- 0781
- Product ID
- 0781-2270_e179c768-32ba-49b7-b59a-55b2cfa54619
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, aspirin, and caffeine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA086996
- Marketing category
- ANDA
- Marketing start
- 2024-09-03
- 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 |
|---|
| 0781-2270-01 | Butalbital, aspirin, and caffeine | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-2270 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [SANDOZ INC] | 2 | Current NDC, 1 package rows | 20241206_0e5e3842-fc6c-4a24-8e5c-522701f7c291.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0781-2270-01 | 00781227001 | 100 CAPSULE in 1 BOTTLE (0781-2270-01) | 100 capsule | 2024-09-03 | No | No | Current |