Over-the-counter drug · ANDA
Nighttime Sleep Aid NDC 69168-439
Doxylamine succinate 25 mg/1 · Tablet · Oral · Allegiant Health
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69168-439Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0439Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-439-06 | 6916804390669168043906 | 120 TABLET in 1 BOTTLE (69168-439-06)Marketed from May 16, 2023 | |
| 69168-439-40 | 6916804394069168043940 | 40 TABLET in 1 BOTTLE (69168-439-40)Marketed from Nov 6, 2023 | |
| 69168-439-84 | 6916804398469168043984 | 2 BLISTER PACK in 1 CARTON (69168-439-84) / 8 TABLET in 1 BLISTER PACKMarketed from May 16, 2023 | |
| 69168-439-98 | 6916804399869168043998 | 200 TABLET in 1 BOTTLE (69168-439-98)Marketed from Nov 6, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Nighttime Sleep Aid
- Generic name (nonproprietary)
- nighttime sleep aid
- Active ingredients
- Doxylamine succinate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Allegiant HealthNDC labeler code 69168
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040564
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69168-439_8accb0e9-d994-4b6a-acc3-4b416f3f65baSPL ID 8accb0e9-d994-4b6a-acc3-4b416f3f65baSPL set ID 3761182c-275b-40f3-a262-9ef5f5a80723RxCUI 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
N469168043906followed by a unit qualifier and the quantityPackage 69168-0439-06. 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(s) helps to reduce difficulty in falling asleep
Excerpt only. Read the full label for complete information.
About NDC 69168-439
- What is NDC 69168-439?
- 69168-439 is the product NDC for Nighttime Sleep Aid, Doxylamine succinate 25 mg/1 tablet, listed with the FDA by Allegiant Health. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nighttime Sleep Aid.
- What is the active ingredient?
- Doxylamine succinate.
- Who is the labeler?
- Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nighttime Sleep Aid?
- 74 other product NDCs are listed under this name. See all Nighttime 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 Nighttime 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) |
|---|---|---|---|---|---|
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Kroger | 41226-793 | 41226-0793-02 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0073 | 83059-0073-08 |
| nighttime sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | Amazon.com Services LLC | 72288-765 | 72288-0765-40 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Grocery Outlet | 85828-439 | 85828-0439-38 |
| Nighttime Sleep Aiddiphenhydramine hcl 50mg | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Grocery Outlet | 85828-410 | 85828-0410-38 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Grocery Outlet, Inc. | 85828-793 | 85828-0793-01 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0122 | — |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | BJWC (Berkley & Jensen / BJ's) | 68391-613 | 68391-0613-92 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | BJWC (Berkley & Jensen / BJ's) | 68391-793 | 68391-0793-09 |
| Nighttime Sleep Aid | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Allegiant Health | 69168-486 | 69168-0486-39 |
Other NDCs under ANDA 040564
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 |
|---|---|---|---|---|
| Night Time Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Advanced Rx LLC | 80513-371 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Better Living Brands, LLC | 21130-986 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | H E B | 37808-886 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Bi-Mart | 37835-831 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Amerisource Bergen | 46122-788 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | L.N.K. International, Inc. | 50844-260 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | L.N.K. International, Inc. | 50844-386 |
| Nighttime Sleep Aid | Doxylamine succinate 25 mg/1 | TabletOral | Family Dollar Stores, Inc | 55319-439 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | CVS PHARMACY | 69842-386 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Grocery Outlet | 85828-439 |
| Nighttime Sleep-Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Kroger Company | 30142-366 |
| Nocto Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Belmora LLC | 27854-375 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Walgreen Company | 0363-0386 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Kroger Company | 30142-386 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-986 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Meijer Distribution Inc | 41250-986 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-968 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-368 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | ARMY AND AIR FORCE EXCHANGE SERVICE | 55301-986 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | COSTCO WHOLESALE CORPORATION | 63981-986 |
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