Venlafaxine Hydrochloride

Product NDC
63187-481
11-digit product format
631870481
Labeler code
63187
Product ID
63187-481_e9619c8b-343a-468e-9eb1-9f6a0be2b1f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076565
Marketing category
ANDA
Marketing start
2010-07-01
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076565-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28
A076565-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28
A076565-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076565-001AB
A076565-002AB
A076565-003AB

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 UTC2026-02A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076565-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2010-06-288072bd15b7f6…

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 UTC2026-02A076565-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076565-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076565-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076565-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076565-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076565-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076565-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076565-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076565-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076565-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076565-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076565-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076565-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076565-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076565-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076565-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076565-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076565-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076565-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076565-001AB18072bd15b7f6…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313583Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
adeba7dd-bd15-4d8f-b703-24c3a208e740Available 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
63187-481-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE308
63187-481-60Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE608
63187-481-90Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-481-30EA - Each63187-481c121c039-4196-4712-a840-2bc41d298f2312019-08-06
63187-481-60EA - Each63187-481b099e36f-e187-4391-97ef-36fbae9155dd12021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
ETHYLCELLULOSE (7 MPA.S)INACTIVE INGREDIENTH3UP11403CVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71OVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-481VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]8Current NDC, Legacy NDC, 3 package rows20241031_adeba7dd-bd15-4d8f-b703-24c3a208e740.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAvKARE7f224c88-9425-9ef0-01bc-dcf3bdafbd892026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEQPharma, Inc.9e745ad7-be4f-4369-be23-587e1154e4ab2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP9f697c00-f5ec-454a-a66c-503aef5fc6092024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP613658d3-7eb5-4822-961f-f4c6f6b2a2c12024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LPadeba7dd-bd15-4d8f-b703-24c3a208e7402024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
ndc (product): 63187-481
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.9a30e1b5-272b-4109-ad6c-a3c9a895822f2024-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions0aedeaf8-9b6c-4a44-a5fe-9d74516f542d2023-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076565
application number: ANDA076565

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNadeba7dd-bd15-4d8f-b703-24c3a208e7408
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDadeba7dd-bd15-4d8f-b703-24c3a208e7408
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYadeba7dd-bd15-4d8f-b703-24c3a208e7408

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-481-306318704813030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-481-30) 2015-05-010000-00-00NoNoCurrent
63187-481-606318704816060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-481-60) 2015-05-010000-00-00NoNoCurrent
63187-481-906318704819090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63187-481-90) 2015-05-010000-00-00NoNoCurrent