Famciclovir
- Product NDC
- 65862-465
- 11-digit product format
- 658620465
- Labeler code
- 65862
- Product ID
- 65862-465_c372e46a-af0b-43c2-8f33-d20e4c6e27d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famciclovir
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA091114
- Marketing category
- ANDA
- Marketing start
- 2011-03-21
- 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 |
|---|
| 65862-465-30 | Famciclovir | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 19 |
| 65862-465-50 | Famciclovir | 5 in 1 CARTON | TABLET, FILM COATED | 5 | | 19 |
| 65862-465-50 | Famciclovir | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 19 |
| 65862-465-99 | Famciclovir | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FAMCICLOVIR | ACTIVE INGREDIENT | QIC03ANI02 | FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | |
| PENCICLOVIR | ACTIVE MOIETY | 359HUE8FJC | FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-465 | FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 19 | Current NDC, Legacy NDC, 4 package rows | 20240618_fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-465-30 | 65862046530 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-465-30) | | 2011-03-21 | 0000-00-00 | No | No | Current |
| 65862-465-50 | 65862046550 | 5 BLISTER PACK in 1 CARTON (65862-465-50) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 5 blister pack | 2011-03-21 | 0000-00-00 | No | No | Current |
| 65862-465-99 | 65862046599 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-465-99) | | 2011-03-21 | 0000-00-00 | No | No | Current |