ziprasidone mesylate
- Product NDC
- 68083-340
- 11-digit product format
- 680830340
- Labeler code
- 68083
- Product ID
- 68083-340_dae5d774-0982-4b2b-8803-02bd0910d228
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ziprasidone mesylate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Gland Pharma Limited
- Application
- ANDA211908
- Marketing category
- ANDA
- Marketing start
- 2019-12-26
- Substance
- ZIPRASIDONE MESYLATE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ziprasidone mesylate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZIPRASIDONE MESYLATE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X6SAX83JZ |
| Rxcui | 351223 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-340-01 | ziprasidone mesylate | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 10 |
| 68083-340-01 | ziprasidone mesylate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-340 | ZIPRASIDONE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250319_77a10f48-e300-465f-81b5-54be38daa4b3.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 |
|---|
| 68083-340-01 | 68083034001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2019-12-26 | 0000-00-00 | No | No | Current |