NDC 70332-320

Etodolac

Etodolac

Etodolac is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by California Pharmaceuticals, Llc. The primary component is Etodolac.

• Product ID: 70332-320_5d135044-5ff9-180a-e053-2991aa0ab763
• NDC: 70332-320
• Product Type: Human Prescription Drug
• Proprietary Name: Etodolac
• Generic Name: Etodolac
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091134
• Labeler Name: California Pharmaceuticals, LLC
• Substance Name: ETODOLAC
• Active Ingredient Strength: 600 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 70332-320-02

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (70332-320-02)

• Marketing Start Date: 2017-08-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70332-320-02 [70332032002]

Etodolac TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA091134
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-03
• Inactivation Date: 2020-01-31

NDC 70332-320-01 [70332032001]

Etodolac TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA091134
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-03
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ETODOLAC	600 mg/1

OpenFDA Data

• SPL SET ID: 55df91c5-d3cc-3443-e054-00144ff8d46c
• Manufacturer:
  • California Pharmaceuticals, LLC
• UNII:
  • 2M36281008
• RxNorm Concept Unique ID - RxCUI:
  • 310247
• 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]

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

NDC	Brand Name	Generic Name
0093-0892	Etodolac	Etodolac
0093-1118	Etodolac	Etodolac
0093-1122	Etodolac	Etodolac
0093-1893	Etodolac	Etodolac
0093-7172	Etodolac	Etodolac
0185-0675	Etodolac	Etodolac
0185-0687	Etodolac	Etodolac
10544-862	Etodolac	Etodolac
16714-497	Etodolac	Etodolac
16714-498	Etodolac	Etodolac
16714-499	Etodolac	Etodolac
21695-049	Etodolac	Etodolac
21695-050	Etodolac	Etodolac
33261-043	Etodolac	Etodolac
33261-044	Etodolac	Etodolac
35356-324	Etodolac	Etodolac
35356-711	Etodolac	Etodolac
35356-826	Etodolac	Etodolac
42254-052	Etodolac	Etodolac
42254-121	Etodolac	etodolac
42291-404	Etodolac	Etodolac
42291-405	Etodolac	Etodolac
42799-111	Etodolac	Etodolac
68151-0738	Etodolac	Etodolac
68382-273	Etodolac	Etodolac
68382-271	Etodolac	Etodolac
68382-272	Etodolac	Etodolac
68788-6901	Etodolac	Etodolac
68788-9410	Etodolac	Etodolac
68788-7315	Etodolac	Etodolac
68788-7300	Etodolac	Etodolac
68788-7068	Etodolac	Etodolac
68788-9928	Etodolac	Etodolac
68788-9929	Etodolac	Etodolac
68788-9360	Etodolac	Etodolac
68788-9990	Etodolac	Etodolac
68788-9930	Etodolac	Etodolac
69238-1342	Etodolac	Etodolac
69238-1343	Etodolac	Etodolac
70332-320	Etodolac	Etodolac
71335-0092	Etodolac	Etodolac
71335-0183	Etodolac	Etodolac
71335-0399	Etodolac	Etodolac
71335-0602	Etodolac	Etodolac
71335-0640	Etodolac	Etodolac
71335-0126	Etodolac	Etodolac
71335-0982	Etodolac	Etodolac
43063-578	Etodolac	Etodolac
42799-112	Etodolac	Etodolac
43063-671	Etodolac	Etodolac