Famciclovir
- Product NDC
- 0093-8117
- 11-digit product format
- 000938117
- Labeler code
- 0093
- Product ID
- 0093-8117_ce3075f6-1bcc-4cfa-a996-555cb87529ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famciclovir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA077487
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Substance
- FAMCICLOVIR
- Active strength
- 125 mg/1
- Pharmacologic classes
- DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Famciclovir
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FAMCICLOVIR | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QIC03ANI02 |
| Rxcui | 198382, 199192, 199193 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-8117-56 | Famciclovir | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FAMCICLOVIR | ACTIVE INGREDIENT | QIC03ANI02 | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| PENCICLOVIR | ACTIVE MOIETY | 359HUE8FJC | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| HYPROMELLOSE 2910 (50 MPA.S) | INACTIVE INGREDIENT | 1IVH67816N | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-8117 | FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 19 | Current NDC, Legacy NDC, 1 package rows | 20230807_3f02042f-8f51-4ccf-b608-5dcd75d100fb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-8117-56 | 00093811756 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-8117-56) | 2007-09-05 | 0000-00-00 | No | No | Current |
| 0093-8117-99 | 00093811799 | 90909 TABLET, FILM COATED in 1 PAIL (0093-8117-99) | 23-JUN-23 | | | | Current |