Home NDC 52427-632 venlafaxine
Product NDC 52427-632
11-digit product format 524270632
Labeler code 52427
Product ID 52427-632_1b0762be-0db0-b997-b76b-b212a496f82c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name venlafaxine
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Almatica Pharma LLC
Application NDA215429
Marketing category NDA
Marketing start 2022-06-30
Substance VENLAFAXINE BESYLATE MONOHYDRATE
Active strength 112.5 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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215429-001 VENLAFAXINE BESYLATE VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215429-001 7776358 2028-05-16 Drug product 2022-07-20
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.
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 2026-02-19 14:30 UTC 2026-02 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215429-001 6717015 2023-03-27 U-451 Drug substance, Drug product 2022-07-20 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215429-001 6717015 2023-03-27 U-451 Drug substance, Drug product 2022-07-20 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215429-001 6717015 2023-03-27 U-451 Drug substance, Drug product 2022-07-20 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215429-001 6717015 2023-03-27 U-451 Drug substance, Drug product 2022-07-20 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215429-001 6717015 2023-03-27 U-451 Drug substance, Drug product 2022-07-20 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215429-001 6717015 2023-03-27 U-451 Drug substance, Drug product 2022-07-20 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215429-001 6717015 2023-03-27 U-451 Drug substance, Drug product 2022-07-20 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215429-001 6717015 2023-03-27 U-451 Drug substance, Drug product 2022-07-20 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215429-001 6717015 2023-03-27 U-451 Drug substance, Drug product 2022-07-20 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215429-001 6717015 2023-03-27 U-451 Drug substance, Drug product 2022-07-20 e64feba35796…2022-09-29 23:25 UTC 2022-09 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base venlafaxine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VENLAFAXINE BESYLATE MONOHYDRATE 112.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 18XP3YT5NH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2605950 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 52427-632-30 venlafaxine 30 in 1 BOTTLE TABLET, EXTENDED RELEASE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52427-632 VENLAFAXINE TABLET, EXTENDED RELEASE [ALMATICA PHARMA LLC] 3 Current NDC, Legacy NDC, 1 package rows 20241011_e81a2daf-b8b2-7c05-b532-bc775700b100.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 Marketing start Marketing end Sample Exclude flag Status 52427-632-30 52427063230 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52427-632-30) 2022-08-01 0000-00-00 No No Current