Butalbital, Acetaminophen, and Caffeine
- Product NDC
- 53002-6030
- 11-digit product format
- 530026030
- Labeler code
- 53002
- Product ID
- 53002-6030_30e55ecd-0acd-4206-b840-179fc08ab384
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA200243
- Marketing category
- ANDA
- Marketing start
- 2012-09-13
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE
- Active strength
- 50 mg/1; mg/1; mg/1
- Pharmacologic classes
- Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-6030-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-4900-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 53002-6030-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-4900-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 53002-6030-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-4900-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 53002-6030-1 | 2021-04-15 | C162847 | 48780-1 | 9d75b9d0-4900-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 53002-6030-2 | 2021-04-15 | C162847 | 48780-1 | 9d75b9d0-4900-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 53002-6030-3 | 2021-04-15 | C162847 | 48780-1 | 9d75b9d0-4900-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 53002-6030-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4900-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 53002-6030-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4900-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
| 53002-6030-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4900-f424-e053-dadaa90a57ce | Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-6030-1 | Butalbital, Acetaminophen, and Caffeine | 10 in 1 BOTTLE | TABLET | 10 | | 3 |
| 53002-6030-2 | Butalbital, Acetaminophen, and Caffeine | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
| 53002-6030-3 | Butalbital, Acetaminophen, and Caffeine | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-6030 | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 3 package rows | 20210416_cff81c9b-47d9-4769-b42b-ad2724a7c80b.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 |
|---|
| 53002-6030-1 | 53002603001 | 10 TABLET in 1 BOTTLE (53002-6030-1) | 10 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-6030-2 | 53002603002 | 20 TABLET in 1 BOTTLE (53002-6030-2) | 20 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-6030-3 | 53002603003 | 30 TABLET in 1 BOTTLE (53002-6030-3) | 30 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |