Prescription drug · ANDA
Doxylamine Succinate and Pyridoxine Hydrochloride NDC 63629-2184
Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1 · Tablet, Delayed release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2184-1 | 63629218401 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-2184-1)Marketed from Mar 12, 2021 |
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)
- Doxylamine Succinate and Pyridoxine Hydrochloride
- Generic name (nonproprietary)
- doxylamine succinate and pyridoxine hydrochloride, delayed release tablets 10 mg/10 mg
- Active ingredients
- Doxylamine succinate — 10 mg/1Pyridoxine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208518
- Marketing start
- Listing expires
- Other FDA classes
- Analogs/Derivatives (Chemical/Ingredient)Histamine Receptor Antagonists (Mechanism)Vitamin B 6 (Chemical/Ingredient)
- Identifiers
- Product ID 63629-2184_aaf58415-1e55-4d24-ae46-d16708f4c0b7SPL ID aaf58415-1e55-4d24-ae46-d16708f4c0b7SPL set ID c283720d-f9a5-471f-9616-853a70f2b31dRxCUI 1375948UNII V9BI9B5YI2, 68Y4CF58BV
- Pharmacologic class
- Antihistamine; Vitamin B6 Analog
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
N463629218401followed by a unit qualifier and the quantityPackage 63629-2184-01. 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)
Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use Doxylamine succinate and pyridoxine hydrochloride delayed-release tablet has not been studied in women with hyperemesis gravidarum. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are a fixed dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. (1)…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208518
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 |
|---|---|---|---|---|
| Doxylamine Succinate and Pyridoxine Hydrochloridedoxylamine succinate and pyridoxine hydrochloride, delayed release tablets 10 mg/10 mg | Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1 | Tablet, Delayed releaseOral | Par Health USA, LLC | 49884-186 |
| Doxylamine Succinate and Pyridoxine Hydrochloridedoxylamine succinate and pyridoxine hydrochloride, delayed release tablets 10 mg/10 mg | Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 72162-1485 |