Silenor
- Product NDC
- 42847-103
- 11-digit product format
- 428470103
- Labeler code
- 42847
- Product ID
- 42847-103_cd7bcf13-11a5-4866-9fd0-da073bb3a9a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doxepin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Currax Pharmaceuticals LLC
- Application
- NDA022036
- Marketing category
- NDA
- Marketing start
- 2010-08-01
- Substance
- DOXEPIN HYDROCHLORIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Tricyclic Antidepressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Silenor
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXEPIN HYDROCHLORIDE | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3U9A0FE9N5 |
| Rxcui | 966787, 966791, 966793, 966795 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42847-103-03 | Silenor | 30 in 1 BLISTER PACK | TABLET | 30 | | 11 |
| 42847-103-10 | Silenor | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
| 42847-103-30 | Silenor | 30 in 1 BOTTLE | TABLET | 30 | | 11 |
| 42847-103-50 | Silenor | 500 in 1 BOTTLE | TABLET | 500 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| doxepin hydrochloride | ACTIVE INGREDIENT | 3U9A0FE9N5 | SILENOR (DOXEPIN HYDROCHLORIDE) TABLET [PERNIX THERAPEUTICS, LLC] | 4 | |
| doxepin | ACTIVE MOIETY | 5ASJ6HUZ7D | SILENOR (DOXEPIN HYDROCHLORIDE) TABLET [PERNIX THERAPEUTICS, LLC] | 4 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | SILENOR (DOXEPIN HYDROCHLORIDE) TABLET [PERNIX THERAPEUTICS, LLC] | 4 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SILENOR (DOXEPIN HYDROCHLORIDE) TABLET [PERNIX THERAPEUTICS, LLC] | 4 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SILENOR (DOXEPIN HYDROCHLORIDE) TABLET [PERNIX THERAPEUTICS, LLC] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | SILENOR (DOXEPIN HYDROCHLORIDE) TABLET [PERNIX THERAPEUTICS, LLC] | 4 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SILENOR (DOXEPIN HYDROCHLORIDE) TABLET [PERNIX THERAPEUTICS, LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42847-103 | SILENOR (DOXEPIN HYDROCHLORIDE) TABLET [CURRAX PHARMACEUTICALS LLC] | 10 | Current NDC, Legacy NDC, 4 package rows | 20230516_1bec1223-5239-4eb6-a9e8-62444106d2c0.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 |
|---|
| 42847-103-03 | 42847010303 | 30 TABLET in 1 BLISTER PACK (42847-103-03) | 30 tablet | 2010-08-01 | 0000-00-00 | No | No | Current |
| 42847-103-10 | 42847010310 | 100 TABLET in 1 BOTTLE (42847-103-10) | 100 tablet | 2010-08-01 | 0000-00-00 | No | No | Current |
| 42847-103-30 | 42847010330 | 30 TABLET in 1 BOTTLE (42847-103-30) | 30 tablet | 2010-08-01 | 0000-00-00 | No | No | Current |
| 42847-103-50 | 42847010350 | 500 TABLET in 1 BOTTLE (42847-103-50) | 500 tablet | 2010-08-01 | 0000-00-00 | No | No | Current |