BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE
- Product NDC
- 69238-1993
- 11-digit product format
- 692381993
- Labeler code
- 69238
- Product ID
- 69238-1993_f3869a7a-b5f3-4279-b07b-ff01a8c2a286
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York, LLC
- Application
- ANDA074951
- Marketing category
- ANDA
- Marketing start
- 2019-04-01
- Substance
- ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
- Active strength
- 325; 50; 40; 30 mg/1; 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], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ASPIRIN | 325 mg/1 |
| BUTALBITAL | 50 mg/1 |
| CAFFEINE | 40 mg/1 |
| CODEINE PHOSPHATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R16CO5Y76E, KHS0AZ4JVK, 3G6A5W338E, GSL05Y1MN6 |
| Rxcui | 994237 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 69238-1993-1 | 2023-02-03 | C162847 | 48780-1 | f386c64a-2abd-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules safely and effectively. See full prescribing information for BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules, USP, for oral use Initial U.S. Approval: 1990 |
| 69238-1993-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2abd-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules safely and effectively. See full prescribing information for BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules, USP, for oral use Initial U.S. Approval: 1990 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1993-1 | BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE | 100 in 1 BOTTLE | CAPSULE | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1993 | BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20241206_828e30fa-7bb1-486b-80ee-806fce45e4e4.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 |
|---|
| 69238-1993-1 | 69238199301 | 100 CAPSULE in 1 BOTTLE (69238-1993-1) | 100 capsule | 2019-04-01 | 0000-00-00 | No | No | Current |