fluphenazine decanoate
- Product NDC
- 68083-476
- 11-digit product format
- 680830476
- Labeler code
- 68083
- Product ID
- 68083-476_8475631f-7d35-47e8-9b93-26357f757277
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluphenazine decanoate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA215509
- Marketing category
- ANDA
- Marketing start
- 2023-03-30
- Substance
- FLUPHENAZINE DECANOATE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- fluphenazine decanoate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUPHENAZINE DECANOATE | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FMU62K1L3C |
| Rxcui | 859824 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-476-01 | fluphenazine decanoate | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 5 |
| 68083-476-01 | fluphenazine decanoate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-476 | FLUPHENAZINE DECANOATE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 5 | Current NDC, 2 package rows | 20241215_8caa3896-cde1-4cb1-9332-2e92bcf5c1f6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-476-01 | 68083047601 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-476-01) / 5 mL in 1 VIAL, MULTI-DOSE | 2023-03-30 | No | No | Current |