Venlafaxine Hydrochloride

Product NDC
68084-713
11-digit product format
680840713
Labeler code
68084
Product ID
68084-713_38559313-5695-06b2-e063-6394a90a92f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA200834
Marketing category
ANDA
Marketing start
2014-04-07
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200834-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14
A200834-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14
A200834-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200834-001AB
A200834-002AB
A200834-003AB

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
2026-02-19 14:30 UTC2026-02A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-148072bd15b7f6…

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
2026-02-19 14:30 UTC2026-02A200834-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200834-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200834-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200834-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200834-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200834-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200834-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200834-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200834-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200834-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE150 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
313581Internal RxNorm lookup
313583Internal RxNorm lookup
313585Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e05bdeb4-07a9-441e-901b-f2aea550db2bAvailable 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
68084-713-01Venlafaxine Hydrochloride100 in 1 BOX, UNIT-DOSECAPSULE, EXTENDED RELEASE10012
68084-713-11Venlafaxine Hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-713-01EA - Each68084-713a71fba7c-9a04-4288-94bc-1576b7303d6412014-05-02
68084-713-11EA - Each68084-713ba0f61ae-05ba-49e4-8fd9-c35c599fc4ff12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
ETHYLCELLULOSE (20 MPA.S)INACTIVE INGREDIENTBJG0S321QYVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SHELLACINACTIVE INGREDIENT46N107B71OVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SUCROSEINACTIVE INGREDIENTC151H8M554VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-713VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241129_e05bdeb4-07a9-441e-901b-f2aea550db2b.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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.4e3053b9-cdec-4f4d-85ae-2e55cf1cc1852026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.50d3b487-9f65-4e2f-b6eb-9533964f89722026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.ac9b972d-8b8a-4727-90c2-b208f91272fd2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECoupler LLC5358f20f-b864-0aae-e063-6394a90a7eab2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECoupler LLC5359012e-a868-3aa3-e063-6294a90a74e22026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAsclemed USA, Inc.c69d16fd-b82d-4708-aece-ab4f60b29cc62026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions7852be9e-0c1d-47a8-9513-c3a04b3657632026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions28c8f404-1dbd-4140-8959-32624d7c77242026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECardinal Health 107, LLC7588ffdc-034d-4baf-9889-9a0ded265be52026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions33068acd-d361-4cd9-b994-02a7865ff04f2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions812ca864-8230-4c84-a7f4-d1b926dee31a2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions569e10d1-6432-473c-a026-ac438bd77bcd2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HCL ERVENLAFAXINE HCL ERDirect_Rxf32ca617-66e0-41d8-e053-2a95a90ae40a2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEQPharma, Inc.4992698e-5d5a-6468-e063-6394a90ab4042026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.e2d5a2d5-5e55-426c-bc8d-d29729eba7752026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENorthwind Health Company, LLCf757cac4-efa7-668c-e053-6294a90a720d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEMajor Pharmaceuticalsd962f5af-7642-4c6e-b7be-3e089fe488732025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.22980b32-cbae-4f37-9fc0-b47221b2c32e2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0c404290-2806-4756-bca3-2d639b4009632025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNe05bdeb4-07a9-441e-901b-f2aea550db2b12
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNe05bdeb4-07a9-441e-901b-f2aea550db2b12
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNe05bdeb4-07a9-441e-901b-f2aea550db2b12
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDe05bdeb4-07a9-441e-901b-f2aea550db2b12
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDe05bdeb4-07a9-441e-901b-f2aea550db2b12
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDe05bdeb4-07a9-441e-901b-f2aea550db2b12
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYe05bdeb4-07a9-441e-901b-f2aea550db2b12
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYe05bdeb4-07a9-441e-901b-f2aea550db2b12
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYe05bdeb4-07a9-441e-901b-f2aea550db2b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-713-0168084071301100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-713-01) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68084-713-11) 100 blister pack2014-04-070000-00-00NoNoCurrent
68084-713-11680840713111 in 1 BLISTER PACKHistorical