NDC codes

FDA NDC Directory
Product NDC (as listed)55111-549Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0549Add 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 NDC11-digit (billing)PackageCopy
55111-549-015511105490155111054901100 TABLET in 1 BOTTLE (55111-549-01)Marketed from Jun 16, 2008
55111-549-055511105490555111054905500 TABLET in 1 BOTTLE (55111-549-05)Marketed from Jun 16, 2008
55111-549-30551110549305511105493030 TABLET in 1 BOTTLE (55111-549-30)Marketed from Jun 16, 2008
55111-549-60551110549605511105496060 TABLET in 1 BOTTLE (55111-549-60)Marketed from Jun 16, 2008
55111-549-7955111054979551110549791 BLISTER PACK in 1 CARTON (55111-549-79) / 10 TABLET in 1 BLISTER PACKMarketed from Jun 16, 2008
55111-549-90551110549905511105499090 TABLET in 1 BOTTLE (55111-549-90)Marketed from Jun 16, 2008

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 100 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078301
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 55111-549_20a19933-a7c1-3739-c472-272204375d1eSPL ID 20a19933-a7c1-3739-c472-272204375d1eSPL set ID 106d0d7b-925b-74e7-83cb-562144ce1f92RxCUI 313580, 313582, 313584, 313586, 314277UNII 7D7RX5A8MO

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

N455111054901 followed by a unit qualifier and the quantity

Package 55111-0549-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Venlafaxine tablets are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-549

What is NDC 55111-549?
55111-549 is the product NDC for Venlafaxine hydrochloride, Venlafaxine hydrochloride 100 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 6 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?
Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-12524658-0125-1024658-0125-3024658-0125-90
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-12624658-0126-1024658-0126-3024658-0126-90
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-12724658-0127-0524658-0127-3024658-0127-90
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralCoupler LLC67046-039067046-0390-03
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralCoupler LLC67046-052767046-0527-03
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralNorthStar RxLLC72603-74772603-0747-01
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralNorthStar RxLLC72603-74872603-0748-01
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralNorthStar RxLLC72603-74972603-0749-01
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-463270518-4632-00
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralAdvanced Rx of Tennessee, LLC80425-058180425-0581-0180425-0581-0280425-0581-03

All 208 Venlafaxine hydrochloride NDCs

Other NDCs under ANDA 078301

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

FDA NDC Directory listings under ANDA 078301
ProductStrengthForm · routeLabelerProduct NDC
Venlafaxine hydrochlorideVenlafaxine hydrochloride 25 mg/1TabletOralDr. Reddy's Laboratories Limited55111-545
Venlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralDr. Reddy's Laboratories Limited55111-546
Venlafaxine hydrochlorideVenlafaxine hydrochloride 50 mg/1TabletOralDr. Reddy's Laboratories Limited55111-547
Venlafaxine hydrochlorideVenlafaxine hydrochloride 75 mg/1TabletOralDr. Reddy's Laboratories Limited55111-548

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