Prescription drug · ANDA
Doxylamine Succinate and Pyridoxine Hydrochloride NDC 49884-186
Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1 · Tablet, Delayed release · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-186-01 | 4988401860149884018601 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (49884-186-01)Marketed from Dec 19, 2019 |
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)
- 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
- Par Health USA, LLCNDC labeler code 49884
- 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 49884-186_81f18ff6-274e-4134-8113-840407bee3ddSPL ID 81f18ff6-274e-4134-8113-840407bee3ddSPL set ID de265fd1-bc22-4da1-aab5-b5fedd649c8bRxCUI 1375948UNII V9BI9B5YI2, 68Y4CF58BVUPC 0349884186012
- 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
N449884018601followed by a unit qualifier and the quantityPackage 49884-0186-01. 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.…
Excerpt only. Read the full label for complete information.
About NDC 49884-186
- What is NDC 49884-186?
- 49884-186 is the product NDC for Doxylamine Succinate and Pyridoxine Hydrochloride, Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1 tablet, delayed release, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxylamine Succinate and Pyridoxine Hydrochloride (Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg).
- What is the active ingredient?
- Doxylamine succinate, Pyridoxine hydrochloride.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Doxylamine Succinate and Pyridoxine Hydrochloride?
- 5 other product NDCs are listed under this name. See all Doxylamine Succinate and Pyridoxine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxylamine Succinate and Pyridoxine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Doxylamine succinate and Pyridoxine hydrochloride | Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1 | Tablet, Delayed releaseOral | Bionpharma Inc., | 69452-206 | 69452-0206-20 |
| 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 | 63629-2184 | 63629-2184-01 |
| 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 | 72162-1485-01 |
| Doxylamine succinate and pyridoxine hydrochloride | Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1 | Tablet, Delayed releaseOral | Actavis Pharma, Inc. | 0591-2132 | 00591-2132-01 |
| Doxylamine succinate and pyridoxine hydrochloride | Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1 | Tablet, Delayed releaseOral | Analog Pharma | 70505-100 | 70505-0100-10 |
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 | Bryant Ranch Prepack | 63629-2184 |
| 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 |