Venlafaxine

Product NDC
71209-089
11-digit product format
712090089
Labeler code
71209
Product ID
71209-089_5e8d05f3-2a6f-4132-b7e3-9dc90804f2d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA211323
Marketing category
ANDA
Marketing start
2018-01-05
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
225 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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211323-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29
A211323-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29
A211323-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A211323-001AB
A211323-002AB
A211323-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211323-002VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211323-003VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211323-001VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-291e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211323-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211323-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211323-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211323-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211323-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211323-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211323-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211323-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211323-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211323-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211323-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211323-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211323-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211323-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211323-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211323-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211323-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211323-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211323-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211323-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211323-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211323-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211323-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211323-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211323-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211323-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211323-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211323-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211323-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211323-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211323-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211323-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211323-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211323-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211323-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211323-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211323-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211323-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211323-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211323-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE225 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808744Internal RxNorm lookup
808748Internal 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
516e7566-35c2-4a25-88d8-54d9dbc8f6beAvailable 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
71209-089-01Venlafaxine30 in 1 BOTTLETABLET, COATED309
71209-089-04Venlafaxine90 in 1 BOTTLETABLET, COATED909
71209-089-11Venlafaxine1000 in 1 BOTTLETABLET, COATED10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-089VENLAFAXINE TABLET, COATED [CADILA PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 3 package rows20240301_516e7566-35c2-4a25-88d8-54d9dbc8f6be.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
VenlafaxineVENLAFAXINEModavar Pharmaceuticals LLC14b38374-7287-47dd-8ef9-e88bd5b23a262024-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211323
application number: ANDA211323
VenlafaxineVENLAFAXINECadila Pharmaceuticals Limited516e7566-35c2-4a25-88d8-54d9dbc8f6be2024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211323
application number: ANDA211323
ndc (product): 71209-089
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e12021-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211323
application number: ANDA211323

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN516e7566-35c2-4a25-88d8-54d9dbc8f6be9
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD516e7566-35c2-4a25-88d8-54d9dbc8f6be9
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD516e7566-35c2-4a25-88d8-54d9dbc8f6be9
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY516e7566-35c2-4a25-88d8-54d9dbc8f6be9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71209-089-017120900890130 TABLET, COATED in 1 BOTTLE (71209-089-01) 2018-08-160000-00-00NoNoCurrent
71209-089-047120900890490 TABLET, COATED in 1 BOTTLE (71209-089-04) 2018-08-160000-00-00NoNoCurrent
71209-089-11712090089111000 TABLET, COATED in 1 BOTTLE (71209-089-11) 2018-08-160000-00-00NoNoCurrent