Venlafaxine Hydrochloride

Product NDC
71335-2421
Requested package NDC
71335-2421-5
11-digit product format
713352421
Labeler code
71335
Product ID
71335-2421_ebaa2be0-2d61-4ebf-8178-5a92c7d059c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214654
Marketing category
ANDA
Marketing start
2022-09-07
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A214654-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06
A214654-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06
A214654-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214654-001AB
A214654-002AB
A214654-003AB

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 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0684e616aacf4f…
2026-09-14 22:38:342026-08A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0684e616aacf4f…
2026-09-14 22:38:342026-08A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0684e616aacf4f…
2026-08-18 06:07:402026-07A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06caaa826d4ba7…
2026-08-18 06:07:402026-07A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06caaa826d4ba7…
2026-08-18 06:07:402026-07A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214654-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2021-08-06301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214654-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A214654-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A214654-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A214654-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214654-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A214654-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214654-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214654-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214654-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214654-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214654-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214654-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214654-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214654-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214654-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214654-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214654-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214654-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214654-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214654-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214654-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214654-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214654-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214654-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride
Listing expiration
2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
ea5914ab-28f3-4cb3-bade-6eaccac214e4Available 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
71335-2421-1Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902
71335-2421-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE602
71335-2421-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE302
71335-2421-4Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1002
71335-2421-5Venlafaxine Hydrochloride7 in 1 BOTTLECAPSULE, EXTENDED RELEASE72

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2421-1EA - Each71335-24210f8ee009-dca3-4c31-afc8-c4f4b4fe7cb712025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2421VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 5 package rows20240704_ea5914ab-28f3-4cb3-bade-6eaccac214e4.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.963e5599-f9af-45c2-8cf4-13cf52eed6a02026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.33b39416-7981-46fb-ba31-e933a6afcf8b2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSb1d21366-f686-4e20-a10f-0c25f517db382026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsf50029b8-7d05-445a-9d9f-71a1aee6088b2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions5a990dbd-f280-4caf-b950-4703ee98b2302026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsd94e5404-f728-4e4b-af99-8a8e4dfae2272026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsc37a73fa-ceee-4555-a61b-e1e66ad6e97d2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.7fcd7995-81fb-4368-bd4c-3726b2ae363e2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEEpic Pharma, LLC430777f0-347c-4f21-8c5d-55f4e9897e742026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackd7d1319c-500e-4ca0-83a1-a739cfa01cf72026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackea5914ab-28f3-4cb3-bade-6eaccac214e42026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
ndc (package): 71335-2421-5
ndc (product): 71335-2421
ndc11 (package): 71335242105
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackbce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions0a1b6bcd-8d46-44ab-bc5d-65515601d2ff2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.b055df74-51f9-401f-8cca-24269a0163df2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.92b3f73d-d6ca-4d7d-9035-5700f527cb852025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine Hydrochloride ERVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf7a9741b-2dd3-d8f3-e053-6294a90a4d732024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2a85bd43-419c-6ed7-e063-6294a90a84d42024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.1e04fe02-88c9-dafd-e063-6294a90ac4c92024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1bf78b22-a0e3-5f9f-e063-6394a90a30242024-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC19b1543e-d599-a869-e063-6294a90a8e282024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214654
application number: ANDA214654

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNea5914ab-28f3-4cb3-bade-6eaccac214e42
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDea5914ab-28f3-4cb3-bade-6eaccac214e42
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYea5914ab-28f3-4cb3-bade-6eaccac214e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2421-5713352421057 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2421-5) 2024-06-26NoNoCurrent