NDC 71403-049

Sitavig

Acyclovir

Sitavig is a Buccal Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Epi Health, Inc. The primary component is Acyclovir.

• Product ID: 71403-049_2a940f29-623c-4c7f-8630-1a157c13543e
• NDC: 71403-049
• Product Type: Human Prescription Drug
• Proprietary Name: Sitavig
• Generic Name: Acyclovir
• Dosage Form: Tablet, Delayed Release
• Route of Administration: BUCCAL
• Marketing Start Date: 2014-03-20
• Marketing Category: NDA / NDA
• Application Number: NDA203791
• Labeler Name: EPI Health, Inc
• Substance Name: ACYCLOVIR
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71403-049-02

1 BLISTER PACK in 1 CARTON (71403-049-02) > 2 TABLET, DELAYED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2014-03-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71403-049-01 [71403004901]

Sitavig TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA203791
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-03-20
• Marketing End Date: 2019-06-06

NDC 71403-049-02 [71403004902]

Sitavig TABLET, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA203791
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-03-20

Drug Details

Active Ingredients

Ingredient	Strength
ACYCLOVIR	50 mg/1

OpenFDA Data

• SPL SET ID: cd6e902d-5753-49ec-bec8-b27176ed978e
• Manufacturer:
  • EPI Health, Inc
• UNII:
  • X4HES1O11F
• RxNorm Concept Unique ID - RxCUI:
  • 1423662
  • 1493276

Pharmacological Class

• DNA Polymerase Inhibitors [MoA]
• Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Nucleoside Analog [EXT]

NDC Crossover Matching brand name "Sitavig" or generic name "Acyclovir"

NDC	Brand Name	Generic Name
68712-049	Sitavig	Sitavig
71403-049	Sitavig	Sitavig
0093-3630	Acyclovir	acyclovir
0093-8940	Acyclovir	Acyclovir
0093-8943	Acyclovir	Acyclovir
0093-8947	Acyclovir	Acyclovir
0143-9657	Acyclovir	Acyclovir
0143-9658	Acyclovir	Acyclovir
0168-0825	acyclovir	acyclovir
0378-8700	Acyclovir	acyclovir
0378-8712	Acyclovir	Acyclovir
0440-6030	Acyclovir	Acyclovir
0440-7033	acyclovir	acyclovir
0472-0082	Acyclovir	Acyclovir
0591-1159	Acyclovir	acyclovir
0713-0630	Acyclovir	Acyclovir
0904-5789	ACYCLOVIR	ACYCLOVIR
0904-5790	acyclovir	acyclovir
10544-039	Acyclovir	acyclovir
10544-089	Acyclovir	acyclovir
10544-101	Acyclovir	Acyclovir
0187-0993	Zovirax	acyclovir
0187-0994	Zovirax	acyclovir
0378-9735	Zovirax	Acyclovir