Unisom SleepTabs
- Product NDC
- 41167-0063
- 11-digit product format
- 411670063
- Labeler code
- 41167
- Product ID
- 41167-0063_32b4f344-3f75-4804-b8cb-800fe2b508c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine Succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chattem, Inc.
- Application
- ANDA040167
- Marketing category
- ANDA
- Marketing start
- 2016-01-15
- Substance
- DOXYLAMINE SUCCINATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Unisom SleepTabs
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXYLAMINE SUCCINATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V9BI9B5YI2 |
| Rxcui | 1101446, 1101448 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 41167-0063-5 | Unisom SleepTabs | 16 in 1 BLISTER PACK | TABLET | 16 | | 5 |
| 41167-0063-5 | Unisom SleepTabs | 1 in 1 CARTON | TABLET | 1 | | 5 |
| 41167-0063-6 | Unisom SleepTabs | 32 in 1 BOTTLE, PLASTIC | TABLET | 32 | | 5 |
| 41167-0063-6 | Unisom SleepTabs | 1 in 1 CARTON | TABLET | 1 | | 5 |
| 41167-0063-7 | Unisom SleepTabs | 48 in 1 BOTTLE, PLASTIC | TABLET | 48 | | 5 |
| 41167-0063-7 | Unisom SleepTabs | 1 in 1 CARTON | TABLET | 1 | | 5 |
| 41167-0063-8 | Unisom SleepTabs | 80 in 1 BOTTLE, PLASTIC | TABLET | 80 | | 5 |
| 41167-0063-8 | Unisom SleepTabs | 1 in 1 CARTON | TABLET | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41167-0063 | UNISOM SLEEPTABS (DOXYLAMINE SUCCINATE) TABLET [CHATTEM, INC.] | 4 | Current NDC, Legacy NDC, 8 package rows | 20230425_f591d52f-5610-4517-a96f-1ed63deb00bc.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 |
|---|
| 41167-0063-5 | 41167006305 | 1 BLISTER PACK in 1 CARTON (41167-0063-5) / 16 TABLET in 1 BLISTER PACK | 1 blister pack | 2016-01-15 | 0000-00-00 | No | No | Current |
| 41167-0063-6 | 41167006306 | 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-6) / 32 TABLET in 1 BOTTLE, PLASTIC | | 2016-01-15 | 0000-00-00 | No | No | Current |
| 41167-0063-7 | 41167006307 | 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-7) / 48 TABLET in 1 BOTTLE, PLASTIC | | 2016-01-15 | 0000-00-00 | No | No | Current |
| 41167-0063-8 | 41167006308 | 1 BOTTLE, PLASTIC in 1 CARTON (41167-0063-8) / 80 TABLET in 1 BOTTLE, PLASTIC | | 2016-01-15 | 0000-00-00 | No | No | Current |