NDC 76420-042

NAPROXEN

Naproxen

NAPROXEN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Asclemed Usa, Inc.. The primary component is Naproxen.

Product ID76420-042_9de2e2bd-8f31-5721-e053-2995a90a89f5
NDC76420-042
Product TypeHuman Prescription Drug
Proprietary NameNAPROXEN
Generic NameNaproxen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-07-06
Marketing CategoryANDA / ANDA
Application NumberANDA091416
Labeler NameAsclemed USA, Inc.
Substance NameNAPROXEN
Active Ingredient Strength500 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76420-042-01

1 TABLET in 1 BOTTLE, PLASTIC (76420-042-01)
Marketing Start Date2020-02-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76420-042-90 [76420004290]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-05

NDC 76420-042-02 [76420004202]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-05

NDC 76420-042-30 [76420004230]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-05

NDC 76420-042-01 [76420004201]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-05

NDC 76420-042-10 [76420004210]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-05

NDC 76420-042-60 [76420004260]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-05

NDC 76420-042-14 [76420004214]

NAPROXEN TABLET
Marketing CategoryANDA
Application NumberANDA091416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-05

Drug Details

Active Ingredients

IngredientStrength
NAPROXEN500 mg/1

Pharmacological Class

  • Cyclooxygenase Inhibitors [MoA]
  • Anti-Inflammatory Agents
  • Non-Steroidal [CS]
  • Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "NAPROXEN" or generic name "Naproxen"

NDCBrand NameGeneric Name
0054-3630NaproxenNaproxen
0093-1005NaproxenNaproxen
0093-1006NaproxenNaproxen
0143-1346NaproxenNaproxen
0143-1347NaproxenNaproxen
0143-1348NaproxenNaproxen
0143-9908NAPROXENnaproxen sodium
0143-9916NAPROXENnaproxen sodium
0179-1978NaproxenNaproxen
0440-1852NaproxenNaproxen
0440-7852NaproxenNaproxen
0615-1504NaproxenNaproxen
0615-3562NaproxenNaproxen
0615-3563NaproxenNaproxen
0615-7709NaproxenNaproxen
0615-7892NaproxenNaproxen
0615-8094NaproxenNaproxen
10544-010NaproxenNaproxen
10544-016NaproxenNaproxen
10544-019NaproxenNaproxen
10544-044NaproxenNaproxen
10544-061NaproxenNaproxen
10544-111NAPROXENNAPROXEN
10544-277NaproxenNaproxen
10544-278NaproxenNaproxen
10544-614NAPROXENnaproxen sodium
10544-920NaproxenNaproxen
10544-922NaproxenNaproxen
10544-939NaproxenNaproxen
12634-498NaproxenNaproxen
68071-3092NaproxenNaproxen
68071-4006NAPROXENNAPROXEN
68071-3029naproxennaproxen
68071-3066naproxennaproxen
68071-3387NaproxenNaproxen
68071-3345NAPROXENNAPROXEN
68071-4510NAPROXENNAPROXEN
68071-4381NAPROXENNAPROXEN
68134-201NaproxenNaproxen
68151-2894NaproxenNaproxen
68151-2609NaproxenNaproxen
68151-2895NaproxenNaproxen
68382-012NaproxenNaproxen
68382-013NaproxenNaproxen
68382-014NaproxenNaproxen
68387-800NaproxenNaproxen
68387-801NaproxenNaproxen
68387-802NaproxenNaproxen
68462-190NaproxenNaproxen
68462-189NaproxenNaproxen

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