NDC codes

FDA NDC Directory
Product NDC (as listed)21130-814Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21130-0814Add 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
21130-814-05211300814052113008140550 TABLET in 1 BOTTLE (21130-814-05)Marketed from Jun 30, 2023

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

Generic name (nonproprietary)
naproxen sodium diphenhydramine hydrochloride
Active ingredients
Naproxen sodium — 220 mg/1Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
SAFEWAYNDC labeler code 21130
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213663
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 21130-814_463f13c5-0aeb-3fa5-e063-6394a90afe8cSPL ID 463f13c5-0aeb-3fa5-e063-6394a90afe8cSPL set ID ed0f3275-f156-13a3-e053-2a95a90a2ce8RxCUI 1550957UNII 9TN87S3A3C, TC2D6JAD40
Pharmacologic class
Histamine-1 Receptor Antagonist; Nonsteroidal Anti-inflammatory Drug

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

N421130081405 followed by a unit qualifier and the quantity

Package 21130-0814-05. 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)

Uses ■ for relief of occasional sleeplessness when asscoiated with minor aches and pains ■ helps you fall asleep and stay asleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 21130-814

What is NDC 21130-814?
21130-814 is the product NDC for Naproxen Sodium Diphenhydramine Hydrochloride, Naproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by SAFEWAY. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naproxen Sodium Diphenhydramine Hydrochloride.
What is the active ingredient?
Naproxen sodium, Diphenhydramine hydrochloride.
Who is the labeler?
SAFEWAY, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Naproxen Sodium Diphenhydramine Hydrochloride?
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.

Other NDCs under ANDA 213663

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

FDA NDC Directory listings under ANDA 213663
ProductStrengthForm · routeLabelerProduct NDC
Naproxen Sodium and Diphenhydramine HCLDiphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1TabletOralTARGET CORPORATION11673-819
Naproxen Sodium and Diphenhydramine HClNaproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralGranules India Ltd62207-814
Naproxen Sodium Diphenhydramine HClNaproxen sodium 220 mg/1; Diphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralCVS PHARMACY, INC69842-328
Naproxen Sodium Diphenhydramine HCLDiphenhydramine hydrochloride 25 mg/1; Naproxen sodium 220 mg/1TabletOralWalmart79903-204

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