Unisom SleepTabs
- Product NDC
- 41167-0608
- 11-digit product format
- 411670608
- Labeler code
- 41167
- Product ID
- 41167-0608_d16a629c-c038-4ab2-a330-9df512db0288
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine Succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chattem, Inc.
- Application
- ANDA040564
- Marketing category
- ANDA
- Marketing start
- 2026-03-16
- 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#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 41167-0608-0 | 41167060800 | 1 BLISTER PACK in 1 CARTON (41167-0608-0) / 16 TABLET in 1 BLISTER PACK | 1 blister pack | 2026-03-16 | No | No | Historical |
| 41167-0608-1 | 41167060801 | 1 BOTTLE in 1 CARTON (41167-0608-1) / 32 TABLET in 1 BOTTLE | 1 bottle | 2026-03-16 | No | No | Historical |
| 41167-0608-2 | 41167060802 | 1 BOTTLE in 1 CARTON (41167-0608-2) / 48 TABLET in 1 BOTTLE | 1 bottle | 2026-03-16 | No | No | Historical |
| 41167-0608-3 | 41167060803 | 1 BOTTLE in 1 CARTON (41167-0608-3) / 80 TABLET in 1 BOTTLE | 1 bottle | 2026-03-16 | No | No | Historical |
| 41167-0608-4 | 41167060804 | 1 BLISTER PACK in 1 CARTON (41167-0608-4) / 4 TABLET in 1 BLISTER PACK | 1 blister pack | 2026-03-16 | No | No | Historical |