Venlafaxine Hydrochloride
- Product NDC
- 47335-794
- 11-digit product format
- 473350794
- Labeler code
- 47335
- Product ID
- 47335-794_dae15132-d26b-4ea9-b937-da9c282ada48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Venlafaxine Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA091272
- Marketing category
- ANDA
- Marketing start
- 2019-02-15
- Substance
- VENLAFAXINE HYDROCHLORIDE
- Active strength
- 225 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Venlafaxine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VENLAFAXINE HYDROCHLORIDE | 225 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7D7RX5A8MO |
| Rxcui | 808744, 808748, 808751, 808753 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-794-08 | Venlafaxine Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 12 |
| 47335-794-13 | Venlafaxine Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 12 |
| 47335-794-81 | Venlafaxine Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 12 |
| 47335-794-83 | Venlafaxine Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 12 |
| 47335-794-88 | Venlafaxine Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 12 |
| 47335-794-99 | Venlafaxine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 12 |
| 47335-794-99 | Venlafaxine Hydrochloride | 5 in 1 BOX, UNIT-DOSE | TABLET, EXTENDED RELEASE | 5 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| VENLAFAXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 7D7RX5A8MO | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| VENLAFAXINE | ACTIVE MOIETY | GRZ5RCB1QG | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| DIBUTYL SEBACATE | INACTIVE INGREDIENT | 4W5IH7FLNY | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| HYPROMELLOSE 2208 (4000 MPA.S) | INACTIVE INGREDIENT | 39J80LT57T | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMA GLOBAL FZE] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-794 | VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 12 | Current NDC, Legacy NDC, 7 package rows | 20230916_dc989aa7-c4ab-4359-a971-523eb477ef9b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-794-08 | 47335079408 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-794-08) | | 2019-02-15 | 0000-00-00 | No | No | Current |
| 47335-794-13 | 47335079413 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-794-13) | | 2019-02-15 | 0000-00-00 | No | No | Current |
| 47335-794-81 | 47335079481 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-794-81) | | 2019-08-15 | 0000-00-00 | No | No | Current |
| 47335-794-83 | 47335079483 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-794-83) | | 2019-02-15 | 0000-00-00 | No | No | Current |
| 47335-794-88 | 47335079488 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-794-88) | | 2019-02-15 | 0000-00-00 | No | No | Current |
| 47335-794-99 | 47335079499 | 5 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-794-99) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 5 blister pack | 2019-02-15 | 0000-00-00 | No | No | Current |