Nighttime Sleep Aid
- Product NDC
- 50844-386
- 11-digit product format
- 508440386
- Labeler code
- 50844
- Product ID
- 50844-386_b218dc14-c46a-4fef-a17e-ffb3edd284f7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- ANDA040564
- Marketing category
- ANDA
- Marketing start
- 2002-04-11
- 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
- Nighttime Sleep Aid
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-386 | NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [L.N.K. INTERNATIONAL, INC.] | 9 | Current NDC, Legacy NDC, 9 package rows | 20250323_918ad808-ccfd-429f-9052-19905a634606.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 |
|---|
| 50844-386-19 | 50844038619 | 1 BLISTER PACK in 1 CARTON (50844-386-19) / 8 TABLET in 1 BLISTER PACK | 1 blister pack | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-386-22 | 50844038622 | 3 BLISTER PACK in 1 CARTON (50844-386-22) / 16 TABLET in 1 BLISTER PACK | 3 blister pack | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-386-27 | 50844038627 | 2 BLISTER PACK in 1 CARTON (50844-386-27) / 16 TABLET in 1 BLISTER PACK | 2 blister pack | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-386-90 | 50844038690 | 32 TABLET in 1 BOTTLE, PLASTIC (50844-386-90) | 32 tablet | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-386-96 | 50844038696 | 2 BOTTLE, PLASTIC in 1 CARTON (50844-386-96) / 96 TABLET in 1 BOTTLE, PLASTIC | | 2002-04-11 | 0000-00-00 | No | No | Current |