NDC 52959-483

ETODOLAC

Etodolac

ETODOLAC is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by H. J. Harkins Co., Inc. The primary component is Etodolac.

• Product ID: 52959-483_6869dcc1-23e7-4007-e053-2991aa0a4b2c
• NDC: 52959-483
• Product Type: Human Prescription Drug
• Proprietary Name: ETODOLAC
• Generic Name: Etodolac
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-12-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075126
• Labeler Name: H. J. Harkins Co., Inc
• Substance Name: ETODOLAC
• Active Ingredient Strength: 300 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 52959-483-14

14 CAPSULE in 1 VIAL (52959-483-14)

• Marketing Start Date: 2017-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52959-483-14 [52959048314]

ETODOLAC CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075126
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-27
• Inactivation Date: 2020-01-31

NDC 52959-483-21 [52959048321]

ETODOLAC CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075126
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-27
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ETODOLAC	300 mg/1

OpenFDA Data

• SPL SET ID: 6869dcc1-23e6-4007-e053-2991aa0a4b2c
• Manufacturer:
  • H. J. Harkins Co., Inc
• UNII:
  • 2M36281008
• RxNorm Concept Unique ID - RxCUI:
  • 197685
• 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 "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