Home NDC 43063-633 Venlafaxine
Product NDC 43063-633
11-digit product format 430630633
Labeler code 43063
Product ID 43063-633_51176701-749d-f1ac-e063-6294a90ad140
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Venlafaxine
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA078627
Marketing category ANDA
Marketing start 2008-06-13
Substance VENLAFAXINE HYDROCHLORIDE
Active strength 75 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 75 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313586 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 43063-633-90 Venlafaxine 90 in 1 BOTTLE, PLASTIC TABLET 90 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VENLAFAXINE HYDROCHLORIDE ACTIVE INGREDIENT 7D7RX5A8MO VENLAFAXINE (VENLAFAXINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 7 VENLAFAXINE ACTIVE MOIETY GRZ5RCB1QG VENLAFAXINE (VENLAFAXINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VENLAFAXINE (VENLAFAXINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 7 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VENLAFAXINE (VENLAFAXINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 VENLAFAXINE (VENLAFAXINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT VENLAFAXINE (VENLAFAXINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VENLAFAXINE (VENLAFAXINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VENLAFAXINE (VENLAFAXINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 VENLAFAXINE (VENLAFAXINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VENLAFAXINE (VENLAFAXINE) TABLET [PD-RX PHARMACEUTICALS, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-633 VENLAFAXINE TABLET [PD-RX PHARMACEUTICALS, INC.] 18 Current NDC, Legacy NDC, 1 package rows 20240606_18495527-add4-42a5-bbf7-9f8dc2df06af.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 ndc (product): 43063-633 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 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 43063-633-90 43063063390 90 TABLET in 1 BOTTLE, PLASTIC (43063-633-90) 90 tablet 2015-11-25 0000-00-00 No No Current