Butalbital, Acetaminophen, Caffeine
- Product NDC
- 70518-2995
- 11-digit product format
- 705182995
- Labeler code
- 70518
- Product ID
- 70518-2995_c10930fb-a6ab-077e-e053-2a95a90a51d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209587
- Marketing category
- ANDA
- Marketing start
- 2021-01-19
- 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2995 | BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET, COATED [REMEDYREPACK INC.] | 3 | Legacy NDC | 20230324_f6c45ff5-cab8-44f0-8079-7fe92083a61e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-2995-0 | 70518299500 | 30 TABLET, COATED in 1 BLISTER PACK (70518-2995-0) | 2021-01-19 | 0000-00-00 | No | No | Current |
| 70518-2995-1 | 70518299501 | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-2995-1) | 2021-04-28 | 0000-00-00 | No | No | Current |