Tencon
- Product NDC
- 11584-0030
- 11-digit product format
- 115840030
- Labeler code
- 11584
- Product ID
- 11584-0030_18834fb3-9eae-0e94-e063-6394a90accfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- El Dorado Distributors LLC
- Application
- ANDA089987
- Marketing category
- ANDA
- Marketing start
- 2013-10-10
- Substance
- ACETAMINOPHEN; BUTALBITAL
- Active strength
- 325; 50 mg/1; mg/1
- Pharmacologic classes
- Barbiturate [EPC], Barbiturates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tencon
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| BUTALBITAL | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, KHS0AZ4JVK |
| Rxcui | 197426, 1483329 |
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 |
|---|
| 11584-0030-1 | Tencon | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
| BUTALBITAL | ACTIVE INGREDIENT | KHS0AZ4JVK | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
| BUTALBITAL | ACTIVE MOIETY | KHS0AZ4JVK | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11584-0030 | TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [EL DORADO DISTRIBUTORS LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240517_4e4a9925-67aa-4be7-8bb7-c8b058ffe223.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 |
|---|
| 11584-0030-1 | 11584003001 | 100 TABLET in 1 BOTTLE, PLASTIC (11584-0030-1) | 100 tablet | 2013-10-10 | 0000-00-00 | No | No | Current |