Butalbital, Acetaminophen and Caffeine
- Product NDC
- 10135-628
- 11-digit product format
- 101350628
- Labeler code
- 10135
- Product ID
- 10135-628_09ec7682-a3a0-4ca1-a6e8-a55e201fcfb9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen and Caffeine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA207118
- Marketing category
- ANDA
- Marketing start
- 2017-04-01
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CAFFEINE; BUTALBITAL
- Active strength
- 300 mg/1; mg/1; mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Barbiturates [CS],Barbiturate [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-628-01 | Butalbital, Acetaminophen and Caffeine | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-628 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [MARLEX PHARMACEUTICALS INC] | 1 | Legacy NDC, 1 package rows | 20170424_5f6997ee-45d5-4ef9-a829-a284a35a4e72.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10135-628-01 | 10135062801 | 100 in 1 BOTTLE | Historical |