Home NDC 55111-547-05 Venlafaxine hydrochloride
Product NDC 55111-547
Requested package NDC 55111-547-05
11-digit product format 551110547
Labeler code 55111
Product ID 55111-547_20a19933-a7c1-3739-c472-272204375d1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Venlafaxine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA078301
Marketing category ANDA
Marketing start 2008-06-16
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 2026-12-31
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 A078301-001 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 A078301-002 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 A078301-003 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 A078301-004 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 A078301-005 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 A078301-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078301-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078301-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078301-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078301-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078301-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078301-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078301-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078301-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078301-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078301-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078301-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078301-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078301-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078301-005 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 A078301-001 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 A078301-002 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 A078301-003 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 A078301-004 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 A078301-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078301-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078301-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078301-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078301-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078301-005 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 A078301-001 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 A078301-002 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 A078301-003 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 A078301-004 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 A078301-005 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 A078301-001 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 A078301-002 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 A078301-003 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 A078301-004 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 A078301-005 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 A078301-001 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 A078301-002 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 A078301-003 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 A078301-004 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 A078301-005 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.
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 Venlafaxine hydrochloride
Listing expiration 2026-12-31 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 55111-547-01 Venlafaxine hydrochloride 100 in 1 BOTTLE TABLET 100 13 55111-547-05 Venlafaxine hydrochloride 500 in 1 BOTTLE TABLET 500 13 55111-547-30 Venlafaxine hydrochloride 30 in 1 BOTTLE TABLET 30 13 55111-547-60 Venlafaxine hydrochloride 60 in 1 BOTTLE TABLET 60 13 55111-547-79 Venlafaxine hydrochloride 1 in 1 CARTON TABLET 1 13 55111-547-79 Venlafaxine hydrochloride 10 in 1 BLISTER PACK TABLET 10 13 55111-547-90 Venlafaxine hydrochloride 90 in 1 BOTTLE TABLET 90 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-547 VENLAFAXINE HYDROCHLORIDE TABLET [DR. REDDY'S LABORATORIES LIMITED] 13 Current NDC, Legacy NDC, 7 package rows 20221224_106d0d7b-925b-74e7-83cb-562144ce1f92.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 Marketing end Sample Exclude flag Status 55111-547-05 55111054705 500 TABLET in 1 BOTTLE (55111-547-05) 500 tablet 2008-06-16 0000-00-00 No No Current