VENLAFAXINE HYDROCHLORIDE

Product NDC
31722-123
11-digit product format
317220123
Labeler code
31722
Product ID
31722-123_495259b8-9f81-4b6e-aa51-d199aa0edfb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214419
Marketing category
ANDA
Marketing start
2020-10-23
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 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
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
A214419-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21
A214419-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21
A214419-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21
A214419-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214419-001AB
A214419-002AB
A214419-003AB
A214419-004AB

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 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214419-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214419-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214419-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214419-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214419-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214419-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214419-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214419-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214419-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214419-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214419-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214419-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214419-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214419-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214419-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214419-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214419-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214419-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214419-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214419-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214419-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214419-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214419-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214419-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214419-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214419-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214419-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214419-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214419-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214419-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214419-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214419-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214419-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214419-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214419-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214419-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214419-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A214419-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A214419-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A214419-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2020-10-21d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214419-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214419-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214419-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214419-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214419-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214419-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214419-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214419-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214419-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214419-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214419-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214419-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214419-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214419-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214419-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214419-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214419-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214419-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214419-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214419-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214419-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214419-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214419-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214419-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214419-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214419-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214419-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214419-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214419-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214419-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214419-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214419-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214419-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214419-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214419-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214419-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214419-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214419-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214419-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214419-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 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
8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd3Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-123-30VENLAFAXINE HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE302
31722-123-90VENLAFAXINE HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-123-30EA - Each31722-123a3eaa29e-56e9-4c98-9494-b80bdc7a263f12021-01-08
31722-123-90EA - Each31722-12365f23db1-befb-4c1e-8958-db51b998c6da12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-123VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20211120_8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd3.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 HYDROCHLORIDEVENLAFAXINEBluePoint Laboratories5efe1336-c796-4560-8110-a64c80eefb0c2025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214419
application number: ANDA214419
VENLAFAXINE HYDROCHLORIDEVENLAFAXINEXLCare Pharmaceuticals, Inc.68f40801-d35e-464e-ac94-21016b617ea22021-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214419
application number: ANDA214419
VENLAFAXINE HYDROCHLORIDEVENLAFAXINECamber Pharmaceuticals, Inc.8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32021-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214419
application number: ANDA214419
ndc (product): 31722-123

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSN8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSN8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSN8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCD8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCD8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCD8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSY8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSY8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSY8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-123-303172201233030 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-123-30) 2020-10-230000-00-00NoNoCurrent
31722-123-903172201239090 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-123-90) 2020-10-230000-00-00NoNoCurrent