NDC 69036-503

LODINE

Etodolac

LODINE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sallus Laboratories, Llc. The primary component is Etodolac.

• Product ID: 69036-503_6f96a3de-40f5-4d0d-9a6c-3d7fcddfd77c
• NDC: 69036-503
• Product Type: Human Prescription Drug
• Proprietary Name: LODINE
• Generic Name: Etodolac
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-09-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075074
• Labeler Name: Sallus Laboratories, LLC
• Substance Name: ETODOLAC
• Active Ingredient Strength: 400 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 69036-503-30

30 TABLET, FILM COATED in 1 BOTTLE (69036-503-30)

• Marketing Start Date: 2016-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69036-503-30 [69036050330]

LODINE TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA075074
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-09-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ETODOLAC	400 mg/1

OpenFDA Data

• SPL SET ID: 560ffd3c-47c9-4ee3-8f92-07629066ca29
• Manufacturer:
  • Sallus Laboratories, LLC
• UNII:
  • 2M36281008
• RxNorm Concept Unique ID - RxCUI:
  • 206812
  • 197686
• 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 "LODINE" or generic name "Etodolac"

NDC	Brand Name	Generic Name
69036-503	LODINE	LODINE
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