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Etodolac - Medication Information

Product NDC Code 65841-777
Drug Name

Etodolac

Type Generic
Pharm Class Anti-Inflammatory Agents,
Non-Steroidal [CS],
Cyclooxygenase Inhibitors [MoA],
Nonsteroidal Anti-inflammatory Drug [EPC]
Active Ingredients
Etodolac 400 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
RxCUI drug identifier 310245,
310247,
359500
Application Number ANDA091134
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-777-01 100 tablet, film coated, extended release in 1 bottle (65841-777-01)
65841-777-05 500 tablet, film coated, extended release in 1 bottle (65841-777-05)
65841-777-10 1000 tablet, film coated, extended release in 1 bottle (65841-777-10)
65841-777-14 60 tablet, film coated, extended release in 1 bottle (65841-777-14)
65841-777-77 100 blister pack in 1 carton (65841-777-77) / 1 tablet, film coated, extended release in 1 blister pack (65841-777-30)
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Spl product data elements

Usually a list of ingredients in a drug product.
Etodolac Etodolac ETODOLAC ETODOLAC D&C YELLOW NO. 10 ETHYLCELLULOSE (100 MPA.S) FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE TRIACETIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS ORANGE OVAL 271 Etodolac Etodolac ETODOLAC ETODOLAC ETHYLCELLULOSE (100 MPA.S) FD&C BLUE NO. 2 FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE TRIACETIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS GRAY OVAL 272 Etodolac Etodolac ETODOLAC ETODOLAC ETHYLCELLULOSE (100 MPA.S) FD&C BLUE NO. 2 FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE TRIACETIN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS BLUE OVAL 273

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-777-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 400 mg R x only 60 tablets NDC 65841-778-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 500 mg R x only 60 tablets NDC 65841-779-14 in bottle of 60 tablets Etodolac Extended-release Tablets USP, 600 mg R x only 60 tablets Etodolac Extended-release Tablets USP, 400 mg Etodolac Extended-release Tablets USP, 500 mg Etodolac Extended-release Tablets USP, 600 mg

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API