Butalbital, aspirin, and caffeine
- Product NDC
- 0527-1552
- 11-digit product format
- 005271552
- Labeler code
- 0527
- Product ID
- 0527-1552_6b42bae1-bbc0-4337-8836-592b1beb7330
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, aspirin, and caffeine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- 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 |
|---|
| 0527-1552-01 | Butalbital, aspirin, and caffeine | 100 in 1 BOTTLE | CAPSULE | 100 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| BUTALBITAL | ACTIVE INGREDIENT | KHS0AZ4JVK | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| BUTALBITAL | ACTIVE MOIETY | KHS0AZ4JVK | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| METHYL ALCOHOL | INACTIVE INGREDIENT | Y4S76JWI15 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
| TRIMYRISTIN | INACTIVE INGREDIENT | 18L31PSR28 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1552 | BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] | 17 | Current NDC, Legacy NDC, 1 package rows | 20240131_ba60b130-33cd-4db9-92a7-2cab8ded0737.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 |
|---|
| 0527-1552-01 | 00527155201 | 100 CAPSULE in 1 BOTTLE (0527-1552-01) | 100 capsule | 1985-10-11 | 0000-00-00 | No | No | Current |