butalbital and acetaminophen
- Product NDC
- 68047-722
- 11-digit product format
- 680470722
- Labeler code
- 68047
- Product ID
- 68047-722_cddc7e52-4eb8-7f7d-e053-2a95a90a2c5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Larken Laboratories, Inc.
- Application
- ANDA203484
- Marketing category
- ANDA
- Marketing start
- 2015-12-04
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ACETAMINOPHEN
- Active strength
- 25 mg/1; mg/1
- Pharmacologic classes
- Barbiturates [CS],Barbiturate [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 68047-722 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 68047-722 | 68047-722-01 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A203484-001 | ALLZITAL | ACETAMINOPHEN; BUTALBITAL | 325MG;25MG | TABLET / ORAL | AA | RS | 2015-12-04 |
| A203484-002 | BUTALBITAL AND ACETAMINOPHEN | ACETAMINOPHEN; BUTALBITAL | 325MG;50MG | TABLET / ORAL | AA | | 2015-12-04 |
Therapeutic equivalence codes#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68047-722-01 | 68047072201 | 100 TABLET in 1 BOTTLE (68047-722-01) | 100 tablet | 2015-12-04 | 0000-00-00 | No | No | Current |