NDC 68712-049
Sitavig
Acyclovir
Sitavig is a Buccal Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Cipher Pharmaceuticals Us Llc. The primary component is Acyclovir.
| Product ID | 68712-049_4d76b99b-3aba-36b3-e054-00144ff88e88 |
| NDC | 68712-049 |
| 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 | Cipher Pharmaceuticals US LLC |
| 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 | E |
| Listing Certified Through | 2018-12-31 |
Packaging
NDC 68712-049-02
1 BLISTER PACK in 1 CARTON (68712-049-02) > 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 68712-049-01 [68712004901]
Sitavig TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA203791 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-03-20 |
| Marketing End Date | 2014-08-22 |
NDC 68712-049-02 [68712004902]
Sitavig TABLET, DELAYED RELEASE
| Marketing Category | NDA |
| Application Number | NDA203791 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-03-20 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ACYCLOVIR | 50 mg/1 |
OpenFDA Data
| SPL SET ID: | 00f7425a-6236-47ff-a087-f28f8cdb1aec |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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 |
Trademark Results [Sitavig]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SITAVIG 85247490 4044319 Live/Registered |
VECTANS PHARMA 2011-02-21 |
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