Fluphenazine Hydrochloride
- Product NDC
- 68462-338
- 11-digit product format
- 684620338
- Labeler code
- 68462
- Product ID
- 68462-338_b5186569-6be5-4ff2-a95e-f162f76254d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluphenazine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA216350
- Marketing category
- ANDA
- Marketing start
- 2023-11-06
- Substance
- FLUPHENAZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluphenazine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUPHENAZINE HYDROCHLORIDE | 10 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 |
|---|
| 68462-338-01 | Fluphenazine Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 5 |
| 68462-338-05 | Fluphenazine Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 5 |
| 68462-338-14 | Fluphenazine Hydrochloride | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 5 |
| 68462-338-14 | Fluphenazine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-338 | FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 4 | Current NDC, 4 package rows | 20250215_4c3eea71-a7a1-4eda-9871-034ddeb83ed6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68462-338-01 | 68462033801 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-338-01) | | 2023-11-06 | No | No | Current |
| 68462-338-05 | 68462033805 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68462-338-05) | | 2023-11-06 | No | No | Current |
| 68462-338-14 | 68462033814 | 100 BLISTER PACK in 1 CARTON (68462-338-14) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2023-11-06 | No | No | Current |