Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
- Product NDC
- 0591-3220
- 11-digit product format
- 005913220
- Labeler code
- 0591
- Product ID
- 0591-3220_519e2ce9-e4af-4bd7-96fd-8bee4e3b4537
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA020232
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2003-09-18
- Substance
- ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
- Active strength
- 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [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, Acetaminophen, Caffeine, and Codeine Phosphate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| BUTALBITAL | 50 mg/1 |
| CAFFEINE | 40 mg/1 |
| CODEINE PHOSPHATE | 30 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E, GSL05Y1MN6 |
| Rxcui | 993943 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-3220-01 | Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | 100 in 1 BOTTLE | CAPSULE | 100 | 38 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3220-01 | EA - Each | 0591-3220 | e95c8235-3333-4913-bee6-d8ec4dbdca5f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993943 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | PSN | a58819b8-a52c-44a7-9ab0-c74480d98506 | 38 |
| 993943 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | SCD | a58819b8-a52c-44a7-9ab0-c74480d98506 | 38 |
| 993943 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | SY | a58819b8-a52c-44a7-9ab0-c74480d98506 | 38 |
| 993943 | butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | PSN | 908bdfc3-ac28-44c9-aa59-39e7b9b28903 | 3 |
| 993943 | acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | SCD | 908bdfc3-ac28-44c9-aa59-39e7b9b28903 | 3 |
| 993943 | APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule | SY | 908bdfc3-ac28-44c9-aa59-39e7b9b28903 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-3220-01 | 00591322001 | 100 CAPSULE in 1 BOTTLE (0591-3220-01) | 100 capsule | 2003-09-18 | 0000-00-00 | No | No | Current |