Over-the-counter drug · ANDA
CareOne Nighttime Sleep Aid (Doxylamine succinate) NDC 41520-634
Doxylamine succinate 25 mg/1 · Tablet · Oral · American Sales Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41520-634-64 | 4152006346441520063464 | 32 BLISTER PACK in 1 CARTON (41520-634-64) / 1 TABLET in 1 BLISTER PACKMarketed from May 6, 2016 |
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)
- CareOne Nighttime Sleep Aid
- Generic name (nonproprietary)
- doxylamine succinate
- Active ingredients
- Doxylamine succinate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Sales CompanyNDC labeler code 41520
- 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 41520-634_e2094ba5-90c3-4e4a-91ea-c51ba4a09cb7SPL ID e2094ba5-90c3-4e4a-91ea-c51ba4a09cb7SPL set ID f8bfc874-53be-41e8-b59c-d538825761a8RxCUI 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
N441520063464followed by a unit qualifier and the quantityPackage 41520-0634-64. 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 41520-634
- What is NDC 41520-634?
- 41520-634 is the product NDC for CareOne Nighttime Sleep Aid (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by American Sales Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- CareOne Nighttime Sleep Aid (Doxylamine succinate).
- What is the active ingredient?
- Doxylamine succinate.
- Who is the labeler?
- American Sales Company, NDC labeler code 41520. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for CareOne Nighttime Sleep Aid?
- 1 other product NDC are listed under this name. See all CareOne 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 CareOne 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) |
|---|---|---|---|---|---|
| careone nighttime sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-431 | 41520-0431-6241520-0431-67 |
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 |
| 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 |
| 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 |
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