Prescription drug · ANDA
Doxylamine succinate and pyridoxine hydrochloride NDC 0591-2132
Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1 · Tablet, Delayed release · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-2132-01 | 00591213201 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2132-01)Marketed from Jun 21, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Doxylamine succinate and pyridoxine hydrochloride
- Generic name (nonproprietary)
- doxylamine succinate and pyridoxine hydrochloride
- Active ingredients
- Doxylamine succinate — 10 mg/1Pyridoxine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205811
- Marketing start
- Listing expires
- Other FDA classes
- Analogs/Derivatives (Chemical/Ingredient)Histamine Receptor Antagonists (Mechanism)Vitamin B 6 (Chemical/Ingredient)
- Identifiers
- Product ID 0591-2132_a51f5dfd-c4ff-4fea-8a7c-1fc058cd7c11SPL ID a51f5dfd-c4ff-4fea-8a7c-1fc058cd7c11SPL set ID 3670d66e-c1e4-42ce-8760-c3d5accad925RxCUI 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
N400591213201followed by a unit qualifier and the quantityPackage 00591-2132-01. 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 tablets have not been studied in women with hyperemesis gravidarum. Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets is 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.