Over-the-counter drug · ANDA
sleep aid (Doxylamine succinate) NDC 0363-3462
Doxylamine succinate 25 mg/1 · Tablet · Oral · Walgreen Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0363-3462Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-3462Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-3462-80 | 0036334628000363346280 | 1 BOTTLE in 1 CARTON (0363-3462-80) / 96 TABLET in 1 BOTTLEMarketed 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)
- 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
- Marketing end
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0363-3462_dd20fa8c-fc10-42e0-ab05-415b2a46928dSPL ID dd20fa8c-fc10-42e0-ab05-415b2a46928dSPL set ID 489ee606-15f4-4032-a62b-35c8844f1a26RxCUI 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
N400363346280followed by a unit qualifier and the quantityPackage 00363-3462-80. 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 0363-3462
- What is NDC 0363-3462?
- 0363-3462 is the product NDC for 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?
- 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 sleep aid?
- 58 other product NDCs are listed under this name. See all sleep aid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other sleep aid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Amazon.com Services LLC | 72288-432 | 72288-0432-01 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0075 | 83059-0075-08 |
| Sleep Aidaconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, ignatia amara, kali phosphoricum, passiflora incarnata, phosphorus, pulsatilla, and valeriana officinalis. | Aconitum napellus whole 10 [hp_X]/59mL + 15 more ingredients | LiquidOral | King Bio Inc. | 57955-9986 | 57955-9986-02 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | Walgreens | 0363-9236 | 00363-9236-50 |
| Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | WALMART INC. (see also Equate) | 79903-426 | 79903-0426-24 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | TARGET Corporation | 82442-530 | 82442-0530-3282442-0530-60 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | WALGREENS | 0363-6130 | 00363-6130-2400363-6130-48 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-368 | 51316-0368-22 |
| sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Publix Super Markets Inc | 56062-441 | 56062-0441-01 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Company name: Topco Associates, LLC | 76162-911 | 76162-0911-1276162-0911-2476162-0911-48 |
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 | 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 |
| ultra sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Walgreen Company | 0363-8011 |
| Unisom SleepTabsdoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Chattem, Inc. | 41167-0063 |
Showing 20 of 22.