Home NDC 57664-394 Venlafaxine
Product NDC 57664-394
11-digit product format 576640394
Labeler code 57664
Product ID 57664-394_4a916be7-abd4-8771-e063-6394a90a86eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Venlafaxine
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA078627
Marketing category ANDA
Marketing start 2008-06-13
Substance VENLAFAXINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078627-001 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 A078627-002 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 A078627-003 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 A078627-004 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 A078627-005 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 215 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 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Venlafaxine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VENLAFAXINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7D7RX5A8MO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313580 Internal RxNorm lookup 313582 Internal RxNorm lookup 313584 Internal RxNorm lookup 313586 Internal RxNorm lookup 314277 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 57664-394-88 Venlafaxine 100 in 1 BOTTLE TABLET 100 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VENLAFAXINE HYDROCHLORIDE ACTIVE INGREDIENT 7D7RX5A8MO VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 VENLAFAXINE ACTIVE MOIETY GRZ5RCB1QG VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57664-394 VENLAFAXINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 Current NDC, Legacy NDC, 1 package rows 20231031_55889b3d-74c9-4638-9a14-6a4ca3a99f7f.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Venlafaxine VENLAFAXINE PD-Rx Pharmaceuticals, Inc. 18495527-add4-42a5-bbf7-9f8dc2df06af 2026-05-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078627 application number: ANDA078627 Venlafaxine VENLAFAXINE Golden State Medical Supply, Inc. c2a3283f-ba30-f506-e053-2995a90a9378 2026-04-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078627 application number: ANDA078627 Venlafaxine VENLAFAXINE Sun Pharmaceutical Industries, Inc. 55889b3d-74c9-4638-9a14-6a4ca3a99f7f 2026-02-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078627 application number: ANDA078627 ndc (product): 57664-394 Venlafaxine VENLAFAXINE Aphena Pharma Solutions - Tennessee, LLC 2887a463-2da1-4f8d-afef-f4c88d31e04d 2021-11-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078627 application number: ANDA078627
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 57664-394-88 57664039488 100 TABLET in 1 BOTTLE (57664-394-88) 100 tablet 2008-06-13 0000-00-00 No No Current