Vistide
- Product NDC
- 61958-0101
- 11-digit product format
- 619580101
- Labeler code
- 61958
- Product ID
- 61958-0101_cc1a8d88-6b17-49dd-9e47-a19a3a4b0f44
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CIDOFOVIR
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gilead Sciences, Inc.
- Application
- NDA020638
- Marketing category
- NDA
- Marketing start
- 1996-06-26
- Marketing end
- 0000-00-00
- Substance
- CIDOFOVIR
- Active strength
- 75 mg/mL
- Pharmacologic classes
- Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 28c2bc40-7d76-a467-8926-be43e330e768 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61958-0101-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-83f8-f424-e053-dadaa90a57ce | VISTIDE ® (cidofovir injection) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61958-0101-1 | Vistide | 1 in 1 CARTON | INJECTION | 1 | 6 | |
| 61958-0101-1 | Vistide | 5 mL in 1 VIAL, SINGLE-USE | INJECTION | 5 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61958-0101-1 | ML - Milliliter | 61958-0101 | 805ef583-af92-44cd-a02c-c438c29514bc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CIDOFOVIR | ACTIVE INGREDIENT | JIL713Q00N | VISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.] | 6 | |
| CIDOFOVIR ANHYDROUS | ACTIVE MOIETY | 768M1V522C | VISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.] | 6 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | VISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | VISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | VISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.] | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61958-0101 | VISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.] | 6 | Legacy NDC, 2 package rows | 20130928_90639fc6-0295-4115-98f0-054b783850ce.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199388 | cidofovir 375 MG in 5 ML Injection | PSN | 90639fc6-0295-4115-98f0-054b783850ce | 6 |
| 211248 | Vistide 375 MG in 5 ML Injection | PSN | 90639fc6-0295-4115-98f0-054b783850ce | 6 |
| 211248 | 5 ML cidofovir 75 MG/ML Injection [Vistide] | SBD | 90639fc6-0295-4115-98f0-054b783850ce | 6 |
| 199388 | 5 ML cidofovir 75 MG/ML Injection | SCD | 90639fc6-0295-4115-98f0-054b783850ce | 6 |
| 211248 | 5 ML Vistide 75 MG/ML Injection | SY | 90639fc6-0295-4115-98f0-054b783850ce | 6 |
| 199388 | cidofovir 375 MG per 5 ML Injection | SY | 90639fc6-0295-4115-98f0-054b783850ce | 6 |
| 211248 | Vistide 375 MG per 5 ML Injection | SY | 90639fc6-0295-4115-98f0-054b783850ce | 6 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 61958-0101-1 | 61958010101 | 1 in 1 CARTON | Historical |