Fluphenazine Hydrochloride
- Product NDC
- 0527-1789
- 11-digit product format
- 005271789
- Labeler code
- 0527
- Product ID
- 0527-1789_59cf1ea7-b827-4780-bf94-cd3446d6dcc3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluphenazine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA089743
- Marketing category
- ANDA
- Marketing start
- 1988-08-25
- Substance
- FLUPHENAZINE HYDROCHLORIDE
- Active strength
- 2.5 mg/1
- 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZOU145W1XL |
| Rxcui | 859841, 860918, 865117, 865123 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-1789-01 | Fluphenazine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 18 |
| 0527-1789-05 | Fluphenazine Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUPHENAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | ZOU145W1XL | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| FLUPHENAZINE | ACTIVE MOIETY | S79426A41Z | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1789 | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [LANNETT COMPANY, INC.] | 18 | Current NDC, Legacy NDC, 2 package rows | 20241121_6cd6ba35-3481-48c1-87db-dc74ce9d7d75.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 |
|---|
| 0527-1789-01 | 00527178901 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1789-01) | 1988-08-25 | 0000-00-00 | No | No | Current |
| 0527-1789-05 | 00527178905 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1789-05) | 1988-08-25 | 0000-00-00 | No | No | Current |