Butalbital and Acetaminophen
- Product NDC
- 0722-7075
- 11-digit product format
- 007227075
- Labeler code
- 0722
- Product ID
- 0722-7075_8b576b84-67c7-4780-9c80-7c2af5283c58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Nexgen Pharma, Inc.
- Application
- ANDA090956
- Marketing category
- ANDA
- Marketing start
- 2011-08-23
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ACETAMINOPHEN
- Active strength
- 50 mg/1; mg/1
- Pharmacologic classes
- Barbiturates [CS],Barbiturate [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7dea7767-9f52-b60a-5435-33cb9cc28bae | Product name | 4 | 20250124 |
| 6338270f-96cb-0ecb-6fbb-0a9bc78001f4 | Product name | 7 | 20250116 |
| 11939cf5-0ea7-5df5-5127-00a7ce07fd7f | Product name | 5 | 20250115 |
| 0ca83774-3f79-b837-5d6f-c210102f3bc8 | Product name | 6 | 20250114 |
| 88300afc-e1c4-ad17-c80b-4957f1b809a5 | Product name | 5 | 20250113 |
| 79e1734e-f721-4d46-978a-be382f771672 | Product name | 2 | 20230110 |
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 103b151b-b17f-42ac-8624-3ef62f5e2975 | Product name | 2 | 20200507 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 332e86c3-7875-ca6e-f934-2206d2b31996 | Product name | 1 | 20140508 |
| 3ed6b849-48b8-8899-c288-6eeb396123b6 | Product name | 1 | 20140508 |
| 7dfac40f-a405-cd2e-7c06-3059ec0e1092 | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| e01133ad-4dcd-c7f3-454b-2ff569ee160a | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0722-7075-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-13bf-a910-e053-dadaa90a0b85 | Butalbital and Acetaminophen Tablets 50 mg/300 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0722-7075-01 | Butalbital and Acetaminophen | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 6 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | BUTALBITAL AND ACETAMINOPHEN TABLET [NEXGEN PHARMA, INC.] | 4 | |
| BUTALBITAL | ACTIVE INGREDIENT | KHS0AZ4JVK | BUTALBITAL AND ACETAMINOPHEN TABLET [NEXGEN PHARMA, INC.] | 4 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | BUTALBITAL AND ACETAMINOPHEN TABLET [NEXGEN PHARMA, INC.] | 4 | |
| BUTALBITAL | ACTIVE MOIETY | KHS0AZ4JVK | BUTALBITAL AND ACETAMINOPHEN TABLET [NEXGEN PHARMA, INC.] | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1249617 | butalbital 50 MG / acetaminophen 300 MG Oral Tablet | PSN | 669e3bd0-fbd9-423c-8654-a78fe650e3e2 | 6 |
| 1249617 | acetaminophen 300 MG / butalbital 50 MG Oral Tablet | SCD | 669e3bd0-fbd9-423c-8654-a78fe650e3e2 | 6 |
| 1249617 | APAP 300 MG / butalbital 50 MG Oral Tablet | SY | 669e3bd0-fbd9-423c-8654-a78fe650e3e2 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 0722-7075-01 | 00722707501 | 100 in 1 BOTTLE, PLASTIC | Historical |