NDC 12634-498

Naproxen

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

Product ID	12634-498_35b8ec82-7260-5925-e054-00144ff8d46c
NDC	12634-498
Product Type	Human Prescription Drug
Proprietary Name	Naproxen
Generic Name	Naproxen
Dosage Form	Tablet
Route of Administration	ORAL
Marketing Start Date	2010-02-18
Marketing Category	ANDA / ANDA
Application Number	ANDA075927
Labeler Name	Apotheca Inc.
Substance Name	NAPROXEN
Active Ingredient Strength	250 mg/1
Pharm Classes	Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude Flag	N
Listing Certified Through	2019-12-31

Packaging

NDC 12634-498-00

10 TABLET in 1 BOTTLE (12634-498-00)

Marketing Start Date	2010-02-18
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 12634-498-78 [12634049878]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-91 [12634049891]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-74 [12634049874]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-67 [12634049867]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-82 [12634049882]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-45 [12634049845]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-59 [12634049859]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-80 [12634049880]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-66 [12634049866]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-99 [12634049899]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-09 [12634049809]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-42 [12634049842]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-63 [12634049863]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-97 [12634049897]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-54 [12634049854]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-52 [12634049852]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-57 [12634049857]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-96 [12634049896]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-50 [12634049850]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-60 [12634049860]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-84 [12634049884]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-90 [12634049890]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-95 [12634049895]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-01 [12634049801]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-85 [12634049885]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-00 [12634049800]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-40 [12634049840]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-61 [12634049861]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-93 [12634049893]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-79 [12634049879]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-94 [12634049894]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-71 [12634049871]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Billing Unit	EA
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-98 [12634049898]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-81 [12634049881]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-92 [12634049892]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

NDC 12634-498-69 [12634049869]

Naproxen TABLET

Marketing Category	ANDA
Application Number	ANDA075927
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2010-02-18
Inactivation Date	2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
NAPROXEN	250 mg/1

OpenFDA Data

SPL SET ID:	35b8ec82-725f-5925-e054-00144ff8d46c
Manufacturer	Apotheca Inc.
UNII	57Y76R9ATQ
RxNorm Concept Unique ID - RxCUI	198013
PHarm Class EPC	Nonsteroidal Anti-inflammatory Drug [EPC]
NUI Code	N0000000160 N0000175722 N0000175721

Pharmacological Class

Cyclooxygenase Inhibitors [MoA]
Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
Nonsteroidal Anti-inflammatory Drug [EPC]
Anti-Inflammatory Agents
Non-Steroidal [CS]

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

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