Over-the-counter drug · ANDA
Topcare Sleep Aid (Doxylamine succinate) NDC 76162-159
Doxylamine succinate 25 mg/1 · Tablet · Oral · Topco Associates LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76162-159-62 | 7616201596276162015962 | 24 BLISTER PACK in 1 CARTON (76162-159-62) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 16, 2023 | |
| 76162-159-67 | 7616201596776162015967 | 48 BLISTER PACK in 1 CARTON (76162-159-67) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 24, 2024 |
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)
- Topcare Sleep Aid
- Generic name (nonproprietary)
- doxylamine succinate
- Active ingredients
- Doxylamine succinate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Topco Associates LLCNDC labeler code 76162
- 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 76162-159_d7fff893-f18b-4114-91fe-e9c1b1e3bbc6SPL ID d7fff893-f18b-4114-91fe-e9c1b1e3bbc6SPL set ID d0295e0b-aba8-4cc7-b83c-b494d552413bRxCUI 1101446UNII V9BI9B5YI2UPC 0036800498198
- 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
N476162015962followed by a unit qualifier and the quantityPackage 76162-0159-62. 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 76162-159
- What is NDC 76162-159?
- 76162-159 is the product NDC for Topcare Sleep Aid (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by Topco Associates LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topcare Sleep Aid (Doxylamine Succinate).
- What is the active ingredient?
- Doxylamine succinate.
- Who is the labeler?
- Topco Associates LLC, NDC labeler code 76162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Topcare Sleep Aid?
- 2 other product NDCs are listed under this name. See all Topcare 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 Topcare 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) |
|---|---|---|---|---|---|
| topcare sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | Tablet, CoatedOral | Topco Associates LLC | 76162-603 | 76162-0603-67 |
| TopCare Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Topco Associates LLC | 36800-441 | 36800-0441-64 |
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 | 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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