NDC codes

FDA NDC Directory
Product NDC (as listed)55494-120Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55494-0120Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
55494-120-105549401201055494012010100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10)Marketed from Feb 19, 2018
55494-120-60554940120605549401206060 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60)Marketed from Feb 19, 2018
55494-120-9455494012094554940120941 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Feb 26, 2025 · Sample package
55494-120-9955494012099554940120996 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.NDC labeler code 55494
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

N455494012010 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 55494-120

What is NDC 55494-120?
55494-120 is the product NDC for Bonjesta, Doxylamine succinate 20 mg/1; Pyridoxine hydrochloride 20 mg/1 tablet, extended release, listed with the FDA by Duchesnay USA, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Bonjesta (Doxylamine succinate and pyridoxine hydrochloride).
What is the active ingredient?
Doxylamine succinate, Pyridoxine hydrochloride.
Who is the labeler?
Duchesnay USA, Inc., NDC labeler code 55494. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bonjesta?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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