ELETRIPTAN HYDROBROMIDE tablet, film coated

Eletriptan hydrobromide by

Drug Labeling and Warnings

Eletriptan hydrobromide by is a Prescription medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

HOW SUPPLIED

Eletriptan Hydrobromide Tablets, 40 mg are brown colored, round shaped, biconvex with beveled edge, film-coated tablets, debossed with "923" on one side and plain on the other side and are supplied as follows:

• NDC: 71335-2983-1: 30 Tablets in a BOTTLE

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container.

Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504

PRINCIPAL DISPLAY PANEL

Eletriptan Hydrobromide 40mg Tablets

INGREDIENTS AND APPEARANCE

ELETRIPTAN HYDROBROMIDE 
eletriptan hydrobromide tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71335-2983(NDC:70771-1108)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ELETRIPTAN HYDROBROMIDE (UNII: M41W832TA3) (ELETRIPTAN - UNII:22QOO9B8KI)	ELETRIPTAN	40 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 112 (UNII: X7XJ6RM9Q2)
POVIDONE K30 (UNII: U725QWY32X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BROWN (BROWN)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	923
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-2983-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206409	07/12/2017

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-2983) , RELABEL(71335-2983)