Diclegis NDC 55494-100

NDC codes

FDA NDC Directory

Product NDC (as listed)55494-100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55494-0100Add 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 NDC	11-digit (billing)	Package	Copy
55494-100-10	55494010010	100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)Marketed from May 15, 2013
55494-100-99	55494010099	12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)Marketed from Mar 28, 2014 · 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): Diclegis
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: Duchesnay USA, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021876
Marketing start: May 15, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Analogs/Derivatives (Chemical/Ingredient)Histamine Receptor Antagonists (Mechanism)Vitamin B 6 (Chemical/Ingredient)
Identifiers: Product ID 55494-100_19a108be-4aba-4906-8a5d-35f5b263b1c2SPL ID 19a108be-4aba-4906-8a5d-35f5b263b1c2SPL set ID 8bde08f6-e8bd-4e90-baa7-82e01876a86aRxCUI 1375948, 1375954UNII 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

N455494010010 followed by a unit qualifier and the quantity

Package 55494-0100-10. 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 Dec 3, 2025.

Indications (excerpt from the label)

DICLEGIS is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Limitations of Use DICLEGIS has not been studied in women with hyperemesis gravidarum. DICLEGIS 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021876

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021876
Product	Strength	Form · route	Labeler	Product NDC
Doxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1	Tablet, Delayed releaseOral	Analog Pharma	70505-100