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NDC 70000-0005-01 LEADER SLEEP AID 25 mg/1 Details
LEADER SLEEP AID 25 mg/1
LEADER SLEEP AID is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. The primary component is DOXYLAMINE SUCCINATE.
MedlinePlus Drug Summary
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 70000-0005-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine
Product Information
| NDC | 70000-0005 |
|---|---|
| Product ID | 70000-0005_9ba1fc5a-d503-4e44-90f5-b6ac9606d6f6 |
| Associated GPIs | 60300010100310 |
| GCN Sequence Number | 003707 |
| GCN Sequence Number Description | doxylamine succinate TABLET 25 MG ORAL |
| HIC3 | H2E |
| HIC3 Description | SEDATIVE-HYPNOTICS,NON-BARBITURATE |
| GCN | 11730 |
| HICL Sequence Number | 004482 |
| HICL Sequence Number Description | DOXYLAMINE SUCCINATE |
| Brand/Generic | Generic |
| Proprietary Name | LEADER SLEEP AID |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Doxylamine succinate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | DOXYLAMINE SUCCINATE |
| Labeler Name | Cardinal Health 110, LLC. dba Leader |
| Pharmaceutical Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA040167 |
| Listing Certified Through | n/a |
Package
NDC 70000-0005-01 (70000000501)
| NDC Package Code | 70000-0005-1 |
|---|---|
| Billing NDC | 70000000501 |
| Package | 48 BLISTER PACK in 1 CARTON (70000-0005-1) / 1 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2020-01-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |