Topcare Sleep Aid
- Product NDC
- 76162-159
- 11-digit product format
- 761620159
- Labeler code
- 76162
- Product ID
- 76162-159_d7fff893-f18b-4114-91fe-e9c1b1e3bbc6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine Succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA040167
- Marketing category
- ANDA
- Marketing start
- 2023-06-16
- Substance
- DOXYLAMINE SUCCINATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| V9BI9B5YI2 | DOXYLAMINE SUCCINATE | 562-10-7 | DOXYLAMINE SUCCINATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-159-62 | 76162015962 | 24 BLISTER PACK in 1 CARTON (76162-159-62) / 1 TABLET in 1 BLISTER PACK | 24 blister pack | 2023-06-16 | No | No | Historical |
| 76162-159-67 | 76162015967 | 48 BLISTER PACK in 1 CARTON (76162-159-67) / 1 TABLET in 1 BLISTER PACK | 48 blister pack | 2024-01-24 | No | No | Historical |