NDC 70505-100

NDC codes

FDA NDC Directory

Product NDC (as listed)70505-100Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70505-0100Add 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
70505-100-10	70505010010	100 TABLET, DELAYED RELEASE in 1 BOTTLE (70505-100-10)Marketed from Nov 15, 2018

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
Active ingredients: Doxylamine succinate — 10 mg/1Pyridoxine hydrochloride — 10 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Analog Pharma
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021876
Marketing start: Nov 15, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Analogs/Derivatives (Chemical/Ingredient)Histamine Receptor Antagonists (Mechanism)Vitamin B 6 (Chemical/Ingredient)
Identifiers: Product ID 70505-100_59e091eb-f626-4083-b134-8d648d28b918SPL ID 59e091eb-f626-4083-b134-8d648d28b918SPL set ID 76d10d65-0279-4e86-8104-cade4343f839RxCUI 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

N470505010010 followed by a unit qualifier and the quantity

Package 70505-0100-10. 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)

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 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. ( 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
Diclegisdoxylamine succinate and pyridoxine hydrochloride	Doxylamine succinate 10 mg/1; Pyridoxine hydrochloride 10 mg/1	Tablet, Delayed releaseOral	Duchesnay USA, Inc.	55494-100

Doxylamine succinate and pyridoxine hydrochloride NDC 70505-100