Home NDC 68462-338 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216350-001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 A216350-002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 A216350-003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 A216350-004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A216350-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216350-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216350-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216350-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216350-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216350-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216350-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216350-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216350-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216350-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216350-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216350-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216350-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216350-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216350-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216350-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216350-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216350-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216350-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216350-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216350-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216350-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216350-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216350-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216350-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216350-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216350-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216350-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216350-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216350-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216350-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216350-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216350-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216350-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216350-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216350-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216350-001 FLUPHENAZINE HYDROCHLORIDE 1MG TABLET / ORAL AB 2023-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216350-002 FLUPHENAZINE HYDROCHLORIDE 2.5MG TABLET / ORAL AB 2023-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216350-003 FLUPHENAZINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2023-11-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216350-004 FLUPHENAZINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-11-06 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZOU145W1XL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859841 Internal RxNorm lookup 860918 Internal RxNorm lookup 865117 Internal RxNorm lookup 865123 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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