NDC codes

FDA NDC Directory
Product NDC (as listed)63629-8516Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-8516Add 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
63629-8516-16362985160163629851601500 TABLET in 1 BOTTLE (63629-8516-1)Marketed from Oct 30, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Naproxen Sodium
Generic name (nonproprietary)
naproxen sodium
Active ingredients
Naproxen sodium — 550 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212199
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 63629-8516_5c995236-3a38-45a1-8db2-8c59960a0554SPL ID 5c995236-3a38-45a1-8db2-8c59960a0554SPL set ID bee7b482-8ba5-411d-90ee-de00df50d2b7RxCUI 849431UNII 9TN87S3A3C

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

N463629851601 followed by a unit qualifier and the quantity

Package 63629-8516-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis Naproxen sodium tablets are also indicated for: the relief of the signs and symptoms of: tendonitis bursitis acute gout the management of: pain primary dysmenorrhea Naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • polyarticular juvenile idiopathic arthritis Naproxen sodium tablets are also indicated for: the relief of the signs and symptoms of: • tendonitis • bursitis • …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8516

What is NDC 63629-8516?
63629-8516 is the product NDC for Naproxen Sodium, Naproxen sodium 550 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Naproxen Sodium.
What is the active ingredient?
Naproxen sodium.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 63629. 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?
144 other product NDCs are listed under this name. See all Naproxen Sodium NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Naproxen Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
naproxen sodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralAmazon.com Services LLC72288-98872288-0988-75
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralAAA Pharmaceutical, Inc.57344-24457344-0244-03
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-057480425-0574-0180425-0574-0280425-0574-03
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralHYVEE INC42507-24542507-0245-0142507-0245-0842507-0245-14
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralHYVEE INC42507-84442507-0844-0142507-0844-14
Naproxen SodiumNaproxen sodium 220 mg/1Capsule, Liquid filledOralTARGET Corporation11673-65111673-0651-78
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, Film coatedOralSafeway21130-59321130-0593-79
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-053180425-0531-0180425-0531-0280425-0531-03
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-053280425-0532-0180425-0532-0280425-0532-03
Naproxen SodiumNaproxen sodium 220 mg/1Tablet, CoatedOralCHAIN DRUG MARKETING ASSOCIATION, INC.83324-10883324-0108-0183324-0108-2483324-0108-50

All 145 Naproxen Sodium NDCs

Other NDCs under ANDA 212199

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

FDA NDC Directory listings under ANDA 212199
ProductStrengthForm · routeLabelerProduct NDC
Naproxen SodiumNaproxen sodium 275 mg/1TabletOralAsclemed USA, Inc.76420-637
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralAsclemed USA, Inc.76420-627
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralBryant Ranch Prepack71335-2294
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralDirect Rx72189-332
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralBryant Ranch Prepack63629-8517
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralProficient Rx LP71205-631
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-801
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0531
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2333
Naproxen SodiumNaproxen sodium 275 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-432
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0574
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralScieGen Pharmaceuticals, Inc.50228-433
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-7800
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-389
Naproxen SodiumNaproxen sodium 550 mg/1TabletOralBryant Ranch Prepack71335-9663

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