Over-the-counter drug · ANDA
ultra sleep aid (Doxylamine succinate) NDC 0363-8011
Doxylamine succinate 25 mg/1 · Tablet · Oral · Walgreen Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-8011-62 | 0036380116200363801162 | 24 BLISTER PACK in 1 CARTON (0363-8011-62) / 1 TABLET in 1 BLISTER PACKMarketed from Feb 14, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- ultra sleep aid
- Generic name (nonproprietary)
- doxylamine succinate
- Active ingredients
- Doxylamine succinate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Walgreen CompanyNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040167
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0363-8011_98f741b9-ff0d-42a6-8643-a706927d2cbbSPL ID 98f741b9-ff0d-42a6-8643-a706927d2cbbSPL set ID 90a5986d-2555-4c2d-8e41-16537ff1aa36RxCUI 1101446UNII V9BI9B5YI2
- Pharmacologic class
- Antihistamine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400363801162followed by a unit qualifier and the quantityPackage 00363-8011-62. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use • helps to reduce difficulty in falling asleep
Excerpt only. Read the full label for complete information.
About NDC 0363-8011
- What is NDC 0363-8011?
- 0363-8011 is the product NDC for ultra sleep aid (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by Walgreen Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ultra sleep aid (Doxylamine Succinate).
- What is the active ingredient?
- Doxylamine succinate.
- Who is the labeler?
- Walgreen Company, NDC labeler code 0363. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ultra sleep aid?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 040167
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Basic Care Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Amazon.com Services LLC | 72288-441 |
| berkley and jensen sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | BJWC | 68391-441 |
| CareOne Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | American Sales Company | 41520-634 |
| dg health sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Dolgencorp Inc | 55910-909 |
| Good sense sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | L. Perrigo Company | 0113-0441 |
| good sense sleep aid ultradoxylamine succinate | Doxylamine succinate 25 mg/1 | Tablet, CoatedOral | L. Perrigo Company | 0113-4032 |
| good sense sleep aid ultradoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | L. Perrigo Company | 0113-6044 |
| nighttime sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | HyVee Inc | 42507-033 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | CVS Pharmacy | 59779-441 |
| sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Walgreen Company | 0363-3462 |
| sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Rite Aid Corporation | 11822-0441 |
| sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Rite Aid Corporation | 11822-3000 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Meijer Distribution Inc | 41250-441 |
| sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Publix Super Markets Inc | 56062-441 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Amazon.com Services LLC | 72288-432 |
| sleep aid ultradoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Meijer, Inc. | 79481-0096 |
| TopCare Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Topco Associates LLC | 36800-441 |
| Topcare Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Topco Associates LLC | 76162-159 |
| topcare sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | Tablet, CoatedOral | Topco Associates LLC | 76162-603 |
| Unisom SleepTabsdoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Chattem, Inc. | 41167-0063 |
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