VENLAFAXINE HYDROCHLORIDE

Product NDC
46708-793
11-digit product format
467080793
Labeler code
46708
Product ID
46708-793_e3e238db-4388-49bb-aa67-6d73adbb2280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA217767
Marketing category
ANDA
Marketing start
2024-06-10
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217767-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06
A217767-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06
A217767-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217767-001AB
A217767-002AB
A217767-003AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217767-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217767-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-061e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217767-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2024-06-06a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217767-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217767-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217767-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217767-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217767-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217767-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217767-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217767-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217767-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217767-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217767-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217767-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217767-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217767-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217767-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217767-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217767-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217767-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217767-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217767-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217767-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217767-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217767-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217767-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217767-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217767-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217767-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217767-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217767-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217767-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217767-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217767-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217767-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217767-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217767-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217767-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217767-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217767-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217767-003AB11e350fbaab3a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217767-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
VENLAFAXINE HYDROCHLORIDE
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 · 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
e3e238db-4388-49bb-aa67-6d73adbb2280Available 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
46708-793-30VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
46708-793-31VENLAFAXINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001
46708-793-71VENLAFAXINE HYDROCHLORIDE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
46708-793-90VENLAFAXINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901
46708-793-91VENLAFAXINE HYDROCHLORIDE1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-793VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 5 package rows20240612_e3e238db-4388-49bb-aa67-6d73adbb2280.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
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDENorthStar RxLLCb865c175-e75d-4cb4-ac29-dec72226302c2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217767
application number: ANDA217767
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.5c943206-6df8-4fc5-ab1d-d34b9715182c2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217767
application number: ANDA217767
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEAlembic Pharmaceuticals Limitede3e238db-4388-49bb-aa67-6d73adbb22802024-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217767
application number: ANDA217767
ndc (product): 46708-793

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNe3e238db-4388-49bb-aa67-6d73adbb22801
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNe3e238db-4388-49bb-aa67-6d73adbb22801
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNe3e238db-4388-49bb-aa67-6d73adbb22801
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDe3e238db-4388-49bb-aa67-6d73adbb22801
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDe3e238db-4388-49bb-aa67-6d73adbb22801
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDe3e238db-4388-49bb-aa67-6d73adbb22801
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYe3e238db-4388-49bb-aa67-6d73adbb22801
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYe3e238db-4388-49bb-aa67-6d73adbb22801
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYe3e238db-4388-49bb-aa67-6d73adbb22801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-793-304670807933030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-793-30) 2024-06-10NoNoCurrent
46708-793-3146708079331100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-793-31) 2024-06-10NoNoCurrent
46708-793-7146708079371500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-793-71) 2024-06-10NoNoCurrent
46708-793-904670807939090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-793-90) 2024-06-10NoNoCurrent
46708-793-91467080793911000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46708-793-91) 2024-06-10NoNoCurrent