Home NDC 52427-632-30 venlafaxine
Product NDC 52427-632
Requested package NDC 52427-632-30
11-digit product format 524270632
Labeler code 52427
Product ID 52427-632_e80091b4-ac1f-a50e-8ba3-54c794794928
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 2026-11-14 07:37:17 2026-10 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215429-001 VENLAFAXINE BESYLATE EQ 112.5MG BASE TABLET, EXTENDED RELEASE / ORAL RLD, RS 2022-06-29 caaa826d4ba7…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# Patent history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-11-14 07:37:17 2026-10 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215429-001 7776358 2028-05-16 Drug product 2022-07-20 caaa826d4ba7…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…
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
Listing expiration 2027-12-31 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
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