Over-the-counter drug · ANDA
Unisom SleepTabs (Doxylamine succinate) NDC 41167-0608
Doxylamine succinate 25 mg/1 · Tablet · Oral · Chattem, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41167-0608-0 | 4116706080041167060800 | 1 BLISTER PACK in 1 CARTON (41167-0608-0) / 16 TABLET in 1 BLISTER PACKMarketed from Mar 16, 2026 | |
| 41167-0608-1 | 4116706080141167060801 | 1 BOTTLE in 1 CARTON (41167-0608-1) / 32 TABLET in 1 BOTTLEMarketed from Mar 16, 2026 | |
| 41167-0608-2 | 4116706080241167060802 | 1 BOTTLE in 1 CARTON (41167-0608-2) / 48 TABLET in 1 BOTTLEMarketed from Mar 16, 2026 | |
| 41167-0608-3 | 4116706080341167060803 | 1 BOTTLE in 1 CARTON (41167-0608-3) / 80 TABLET in 1 BOTTLEMarketed from Mar 16, 2026 | |
| 41167-0608-4 | 4116706080441167060804 | 1 BLISTER PACK in 1 CARTON (41167-0608-4) / 4 TABLET in 1 BLISTER PACKMarketed from Mar 16, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Unisom SleepTabs
- Generic name (nonproprietary)
- doxylamine succinate
- Active ingredients
- Doxylamine succinate — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chattem, Inc.NDC labeler code 41167
- 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 41167-0608_d16a629c-c038-4ab2-a330-9df512db0288SPL ID d16a629c-c038-4ab2-a330-9df512db0288SPL set ID 7ae32d74-76a0-47e2-9e5c-812426413c4eRxCUI 1101446, 1101448UNII 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
N441167060800followed by a unit qualifier and the quantityPackage 41167-0608-00. 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 41167-0608
- What is NDC 41167-0608?
- 41167-0608 is the product NDC for Unisom SleepTabs (doxylamine succinate), Doxylamine succinate 25 mg/1 tablet, listed with the FDA by Chattem, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Unisom SleepTabs (Doxylamine Succinate).
- What is the active ingredient?
- Doxylamine succinate.
- Who is the labeler?
- Chattem, Inc., NDC labeler code 41167. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Unisom SleepTabs?
- 1 other product NDC are listed under this name. See all Unisom SleepTabs NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Unisom SleepTabs products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Unisom SleepTabsdoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Chattem, Inc. | 41167-0063 | 41167-0063-0541167-0063-0641167-0063-07+1 more |
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 |
|---|---|---|---|---|
| Nocto Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Belmora LLC | 27854-375 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Better Living Brands, LLC | 21130-986 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Strategic Sourcing Services LLC | 70677-1129 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-968 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | H E B | 37808-886 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-986 |
| 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 | Amerisource Bergen | 46122-788 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Meijer Distribution Inc | 41250-986 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Bi-Mart | 37835-831 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Grocery Outlet | 85828-439 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | CVS PHARMACY | 69842-386 |
| Sleep-Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Cardinal Health 110, LLC. DBA Leader | 70000-0567 |
| SLEEP AID 25mgdoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | YYBA CORP | 73581-205 |
| Nighttime Sleep-Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Kroger Company | 30142-366 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Kroger Company | 30142-386 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | COSTCO WHOLESALE CORPORATION | 63981-986 |
| Night Time Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Advanced Rx LLC | 80513-371 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Walgreen Company | 0363-0386 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | L.N.K. International, Inc. | 50844-260 |
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