What is NDC 80425-0471?

80425-0471 is the product NDC for Venlafaxine Hydrochloride, Venlafaxine hydrochloride 75 mg/1 capsule, extended release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Venlafaxine Hydrochloride?

207 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Venlafaxine Hydrochloride NDC 80425-0471

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0471Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0471Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
80425-0471-1	8042504710180425047101	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0471-1)Marketed from Jan 20, 2025
80425-0471-2	8042504710280425047102	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0471-2)Marketed from Jan 20, 2025
80425-0471-3	8042504710380425047103	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0471-3)Marketed from Jan 20, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Venlafaxine Hydrochloride
Generic name (nonproprietary): venlafaxine hydrochloride
Active ingredients: Venlafaxine hydrochloride — 75 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212277
Marketing start: Jan 20, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 80425-0471_2c2ba237-e6f3-fe8b-e063-6294a90ad400SPL ID 2c2ba237-e6f3-fe8b-e063-6294a90ad400SPL set ID 2c2bb0e6-5a73-ff57-e063-6294a90a88d3RxCUI 313585UNII 7D7RX5A8MO
Pharmacologic class: Serotonin and Norepinephrine Reuptake Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480425047101 followed by a unit qualifier and the quantity

Package 80425-0471-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 20, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: • Major Depressive Disorder (MDD) [see Clinical Studies ( 14.1 )] • Generalized Anxiety Disorder (GAD) [see Clinical Studies ( 14.2 )] • Social Anxiety Disorder (SAD) [see Clinical Studies ( 14.3 )] • Panic Disorder (PD) [see Clinical Studies ( 14.4 )] Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: • Major Depressive Disorder (MDD) ( 1 ) • Generalized Anxiety Disorder (GAD) ( 1 ) • Social Anxiety Disorder (SAD) ( 1 ) • Panic Disorder (PD) ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0471

What is NDC 80425-0471?: 80425-0471 is the product NDC for Venlafaxine Hydrochloride, Venlafaxine hydrochloride 75 mg/1 capsule, extended release, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Venlafaxine Hydrochloride.
What is the active ingredient?: Venlafaxine hydrochloride.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Venlafaxine Hydrochloride?: 207 other product NDCs are listed under this name. See all Venlafaxine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Venlafaxine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-125	24658-0125-1024658-0125-3024658-0125-90
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-126	24658-0126-1024658-0126-3024658-0126-90
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 150 mg/1	Capsule, Extended releaseOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-127	24658-0127-0524658-0127-3024658-0127-90
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	Coupler LLC	67046-0390	67046-0390-03
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	Coupler LLC	67046-0527	67046-0527-03
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	NorthStar RxLLC	72603-747	72603-0747-01
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	NorthStar RxLLC	72603-748	72603-0748-01
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 150 mg/1	Capsule, Extended releaseOral	NorthStar RxLLC	72603-749	72603-0749-01
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4632	70518-4632-00
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	Advanced Rx of Tennessee, LLC	80425-0581	80425-0581-0180425-0581-0280425-0581-03

All 208 Venlafaxine Hydrochloride NDCs

Other NDCs under ANDA 212277

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212277
Product	Strength	Form · route	Labeler	Product NDC
Venlafaxine HCL ERvenlafaxine hcl	Venlafaxine hydrochloride 150 mg/1	Capsule, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0194
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-002
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-003
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 150 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-004
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 150 mg/1	Capsule, Extended releaseOral	A-S Medication Solutions	50090-5890
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	A-S Medication Solutions	50090-5942
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	AvPAK	50268-873
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	AvPAK	50268-874
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 150 mg/1	Capsule, Extended releaseOral	AvPAK	50268-875
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	NuCare Pharmaceuticals,Inc.	68071-2393
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-7891
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	Preferred Pharmaceuticals, Inc.	68788-8068
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 150 mg/1	Capsule, Extended releaseOral	Preferred Pharmaceuticals, Inc.	68788-8072
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4280
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	Proficient Rx LP	71205-812
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 150 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	71335-1812
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	71335-1868
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	71335-9605
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 37.5 mg/1	Capsule, Extended releaseOral	Annora Pharma Private Limited	71785-1006
Venlafaxine Hydrochloride	Venlafaxine hydrochloride 75 mg/1	Capsule, Extended releaseOral	Annora Pharma Private Limited	71785-1007

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