Venlafaxine Hydrochloride

Product NDC
71335-1868
11-digit product format
713351868
Labeler code
71335
Product ID
71335-1868_7e6b92dd-caad-4a67-9013-4c0be2e20a60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212277
Marketing category
ANDA
Marketing start
2019-07-08
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1868-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1868-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1868-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1868-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1868-5ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1868-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1868-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1868-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1868-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1868-5367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1868-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1868-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1868-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1868-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1868-5557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1868-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1868-28af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1868-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1868-48af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1868-58af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1868-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1868-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1868-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1868-4834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1868-5834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1868-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1868-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1868-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1868-41332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1868-51332a3947898…d4bfe170f9cd…

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
A212277-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08
A212277-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08
A212277-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212277-001AB
A212277-002AB
A212277-003AB

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 UTC2026-02A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212277-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212277-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212277-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2019-07-088072bd15b7f6…

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 UTC2026-02A212277-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212277-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212277-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212277-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212277-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212277-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212277-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212277-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212277-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212277-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212277-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212277-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212277-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212277-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212277-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212277-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212277-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212277-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212277-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212277-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212277-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212277-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212277-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212277-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212277-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212277-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212277-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212277-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212277-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212277-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212277-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212277-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212277-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212277-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212277-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212277-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212277-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212277-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212277-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212277-001AB18072bd15b7f6…

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 · 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
20a7d922-7f7c-4de4-b5fd-55c13aab060cAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-1868-12024-11-19These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
71335-1868-22024-11-19These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
71335-1868-32024-11-19These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
71335-1868-42024-11-19These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
71335-1868-52024-11-19These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
71335-1868-12024-01-30These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
71335-1868-22024-01-30These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
71335-1868-32024-01-30These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
71335-1868-42024-01-30These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997
71335-1868-52024-01-30These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1868-1Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE90102
71335-1868-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE60102
71335-1868-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30102
71335-1868-4Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100102
71335-1868-5Venlafaxine Hydrochloride7 in 1 BOTTLECAPSULE, EXTENDED RELEASE7102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1868-1EA - Each71335-186877510191-6cf7-4e51-b17d-d917097c23a312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1868VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20241121_20a7d922-7f7c-4de4-b5fd-55c13aab060c.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.c0fa9a3b-692e-2c2e-e053-2995a90aa83a2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.c41d847b-88ba-49a5-9d73-269ac4caa4ed2026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.b18d726e-cdb2-4c80-a49d-330cddee17e92025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.6c1d0d4f-c8e2-4035-8f4e-7a46bfe3f0592025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.653f3f95-98d0-4ce0-bf10-ac7938be690e2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAvPAK2efde38c-250e-d1b9-e063-6394a90a1b742025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2c2bb0e6-5a73-ff57-e063-6294a90a88d32025-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HCL ERVENLAFAXINE HCLAdvanced Rx Pharmacy of Tennessee, LLCd8e00b3d-29de-1de5-e053-2995a90acb512024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack20a7d922-7f7c-4de4-b5fd-55c13aab060c2024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
ndc (product): 71335-1868
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackbaae24d6-e425-4cfc-9a53-3cd223b6d3442024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack1e1119f7-0c2e-4587-a24d-0066f73b2e652024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECamber Pharmaceuticals, Inc.0ee91447-2c23-4519-81cc-550b5416dd6b2024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutionsdf7e0982-3eb0-4bdf-8f7f-4f4a48476ed72023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions52319578-f7cc-4b87-b532-f341854e40b42023-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEProficient Rx LP922388b3-fc1c-46c6-b314-9049bd042df72023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEAnnora Pharma Private Limitede901e476-58bd-4204-baaa-a4634ae65ab32020-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212277
application number: ANDA212277

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN20a7d922-7f7c-4de4-b5fd-55c13aab060c102
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD20a7d922-7f7c-4de4-b5fd-55c13aab060c102
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY20a7d922-7f7c-4de4-b5fd-55c13aab060c102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1868-17133518680190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1868-1) 2021-06-220000-00-00NoNoCurrent
71335-1868-27133518680260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1868-2) 2024-10-110000-00-00NoNoCurrent
71335-1868-37133518680330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1868-3) 2021-06-110000-00-00NoNoCurrent
71335-1868-471335186804100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1868-4) 2024-10-310000-00-00NoNoCurrent
71335-1868-5713351868057 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1868-5) 2024-10-310000-00-00NoNoCurrent