Venlafaxine

Product NDC
70771-1650
11-digit product format
707711650
Labeler code
70771
Product ID
70771-1650_0bf02fa2-e5cd-42d6-ab41-1ecd150b7c57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA215622
Marketing category
ANDA
Marketing start
2022-09-01
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
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215622-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30
A215622-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30
A215622-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30
A215622-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A215622-001AB
A215622-002AB
A215622-003AB
A215622-004AB

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 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215622-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A215622-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A215622-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A215622-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-08-30d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215622-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215622-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215622-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215622-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215622-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215622-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215622-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215622-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215622-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215622-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215622-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215622-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215622-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215622-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215622-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215622-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215622-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215622-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215622-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215622-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215622-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7D7RX5A8MOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808744Internal RxNorm lookup
808748Internal RxNorm lookup
808751Internal RxNorm lookup
808753Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
750333ce-a512-42e1-b9e3-179714b488dfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1650-1Venlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
70771-1650-3Venlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
70771-1650-9Venlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1650VENLAFAXINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 3 package rows20231005_750333ce-a512-42e1-b9e3-179714b488df.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VenlafaxineVENLAFAXINEREMEDYREPACK INC.570beece-6f30-4850-a3bc-636e7cf8d4232026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215622
application number: ANDA215622
VenlafaxineVENLAFAXINEZydus Lifesciences Limited750333ce-a512-42e1-b9e3-179714b488df2023-09-28Exact identifier
application applno (ANDA): 215622
application number: ANDA215622
ndc (product): 70771-1650
VenlafaxineVENLAFAXINEZydus Pharmaceuticals USA Inc.db1d16b3-d1a2-4f41-adff-a87c17689aa02023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215622
application number: ANDA215622

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN750333ce-a512-42e1-b9e3-179714b488df2
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN750333ce-a512-42e1-b9e3-179714b488df2
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSN750333ce-a512-42e1-b9e3-179714b488df2
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN750333ce-a512-42e1-b9e3-179714b488df2
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD750333ce-a512-42e1-b9e3-179714b488df2
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD750333ce-a512-42e1-b9e3-179714b488df2
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCD750333ce-a512-42e1-b9e3-179714b488df2
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD750333ce-a512-42e1-b9e3-179714b488df2
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY750333ce-a512-42e1-b9e3-179714b488df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1650-170771165001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1650-1) 2022-09-010000-00-00NoNoCurrent
70771-1650-37077116500330 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1650-3) 2022-09-010000-00-00NoNoCurrent
70771-1650-97077116500990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1650-9) 2022-09-010000-00-00NoNoCurrent