Fluphenazine Decanoate
- Product NDC
- 63323-272
- 11-digit product format
- 633230272
- Labeler code
- 63323
- Product ID
- 63323-272_a7b2e2cb-f87a-46e7-8230-ec6b585f45cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUPHENAZINE DECANOATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA071413
- Marketing category
- ANDA
- Marketing start
- 2010-12-15
- 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 |
|---|
| 63323-272-05 | Fluphenazine Decanoate | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | | 6 |
| 63323-272-05 | Fluphenazine Decanoate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUPHENAZINE DECANOATE | ACTIVE INGREDIENT | FMU62K1L3C | FLUPHENAZINE DECANOATE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| FLUPHENAZINE | ACTIVE MOIETY | S79426A41Z | FLUPHENAZINE DECANOATE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | FLUPHENAZINE DECANOATE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| SESAME OIL | INACTIVE INGREDIENT | QX10HYY4QV | FLUPHENAZINE DECANOATE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| FLUPHENAZINE DECANOATE | ACTIVE INGREDIENT | FMU62K1L3C | FLUPHENAZINE DECANOATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| FLUPHENAZINE DECANOATE | ACTIVE MOIETY | FMU62K1L3C | FLUPHENAZINE DECANOATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | FLUPHENAZINE DECANOATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
| SESAME OIL | INACTIVE INGREDIENT | QX10HYY4QV | FLUPHENAZINE DECANOATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-272 | FLUPHENAZINE DECANOATE (FLUPHENAZINE DECANOATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241019_f8ba014e-aea0-49bc-8345-4e0a384b484e.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 |
|---|
| 63323-272-05 | 63323027205 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-272-05) / 5 mL in 1 VIAL, MULTI-DOSE | 2010-12-15 | 0000-00-00 | No | No | Current |