Prescription drug · NDA
Bonjesta NDC 55494-120
doxylamine succinate and pyridoxine hydrochloride · Doxylamine succinate 20 mg/1; Pyridoxine hydrochloride 20 mg/1 · Tablet, Extended release · Oral · Duchesnay USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55494-120-10 | 55494012010 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10)Marketed from Feb 19, 2018 | |
| 55494-120-60 | 55494012060 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60)Marketed from Feb 19, 2018 | |
| 55494-120-94 | 55494012094 | 1 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 26, 2025 · Sample package | |
| 55494-120-99 | 55494012099 | 6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99)Marketed from Feb 19, 2018 · Sample package |
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)
- Bonjesta
- Generic name (nonproprietary)
- doxylamine succinate and pyridoxine hydrochloride
- Active ingredients
- Doxylamine succinate — 20 mg/1Pyridoxine hydrochloride — 20 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Duchesnay USA, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209661
- Marketing start
- Listing expires
- Other FDA classes
- Analogs/Derivatives (Chemical/Ingredient)Histamine Receptor Antagonists (Mechanism)Vitamin B 6 (Chemical/Ingredient)
- Identifiers
- Product ID 55494-120_3e4fbcb3-ac64-4673-b46f-a2ce616d4374SPL ID 3e4fbcb3-ac64-4673-b46f-a2ce616d4374SPL set ID dba60bb4-54ff-4e06-b8d2-acbbd3717666RxCUI 1999651, 1999657UNII V9BI9B5YI2, 68Y4CF58BVUPC 0355494120605
- 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
N455494012010followed by a unit qualifier and the quantityPackage 55494-0120-10. 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)
BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use BONJESTA has not been studied in women with hyperemesis gravidarum. BONJESTA is a fixed dose combination drug product of 20 mg doxylamine succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a Vitamin B 6 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.