Fluphenazine Hydrochloride
- Product NDC
- 0121-0653
- 11-digit product format
- 001210653
- Labeler code
- 0121
- Product ID
- 0121-0653_4bf945f4-e607-409c-80f5-90195005d6a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluphenazine Hydrochloride
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA074725
- Marketing category
- ANDA
- Marketing start
- 2010-09-01
- Substance
- FLUPHENAZINE HYDROCHLORIDE
- Active strength
- 5 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 Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUPHENAZINE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZOU145W1XL |
| Rxcui | 861848 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-0653-04 | Fluphenazine Hydrochloride | 120 mL in 1 BOTTLE, DROPPER | SOLUTION, CONCENTRATE | 120 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Fluphenazine Hydrochloride | ACTIVE INGREDIENT | ZOU145W1XL | FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Fluphenazine | ACTIVE MOIETY | S79426A41Z | FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PHARMACEUTICAL ASSOCIATES, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0653 | FLUPHENAZINE HYDROCHLORIDE SOLUTION, CONCENTRATE [PAI HOLDINGS, LLC DBA PAI PHARMA] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250210_0860b3f3-3116-40f8-bcb0-e5c47731bdc8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-0653-04 | 00121065304 | 120 mL in 1 BOTTLE, DROPPER (0121-0653-04) | 120 ml | 2010-09-01 | 0000-00-00 | No | No | Current |