Prescription drug · ANDA

Nortriptyline Hydrochloride NDC 63187-396

Nortriptyline hydrochloride 25 mg/1 · Capsule · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-396Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0396Add 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
63187-396-30631870396306318703963030 CAPSULE in 1 BOTTLE (63187-396-30)Marketed from Oct 3, 2016
63187-396-60631870396606318703966060 CAPSULE in 1 BOTTLE (63187-396-60)Marketed from Oct 3, 2016
63187-396-90631870396906318703969090 CAPSULE in 1 BOTTLE (63187-396-90)Marketed from Oct 3, 2016

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)
Nortriptyline Hydrochloride
Generic name (nonproprietary)
nortriptyline hydrochloride
Active ingredients
Nortriptyline hydrochloride — 25 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075520
Marketing start
Listing expires
Identifiers
Product ID 63187-396_18775e95-6eef-4cec-bf3f-3a9d5e8550d1SPL ID 18775e95-6eef-4cec-bf3f-3a9d5e8550d1SPL set ID 59a65e6f-b812-4195-b85b-c412fb902c93RxCUI 317136UNII 00FN6IH15DUPC 0363187396305
Pharmacologic class
Tricyclic Antidepressant

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

N463187039630 followed by a unit qualifier and the quantity

Package 63187-0396-30. 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 Nortriptyline hydrochloride is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-396

What is NDC 63187-396?
63187-396 is the product NDC for Nortriptyline Hydrochloride, Nortriptyline hydrochloride 25 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nortriptyline Hydrochloride.
What is the active ingredient?
Nortriptyline hydrochloride.
Who is the labeler?
Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nortriptyline Hydrochloride?
77 other product NDCs are listed under this name. See all Nortriptyline 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 Nortriptyline Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nortriptyline HydrochlorideNortriptyline hydrochloride 10 mg/1CapsuleOralREMEDYREPACK INC.70518-476670518-4766-00
Nortriptyline HydrochlorideNortriptyline hydrochloride 25 mg/1CapsuleOralCoupler LLC67046-166167046-1661-03
Nortriptyline HydrochlorideNortriptyline hydrochloride 25 mg/1CapsuleOralAmerican Health Packaging60687-91160687-0911-01
Nortriptyline HydrochlorideNortriptyline hydrochloride 10 mg/1CapsuleOralAmerican Health Packaging60687-90060687-0900-01
Nortriptyline HydrochlorideNortriptyline hydrochloride 25 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-90960760-0909-30
Nortriptyline HydrochlorideNortriptyline hydrochloride 10 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-890068788-8900-03
Nortriptyline HydrochlorideNortriptyline hydrochloride 25 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-053480425-0534-0180425-0534-0280425-0534-03
Nortriptyline HydrochlorideNortriptyline hydrochloride 50 mg/1CapsuleOralCoupler LLC67046-153067046-1530-03
Nortriptyline HydrochlorideNortriptyline hydrochloride 75 mg/1CapsuleOralREMEDYREPACK INC.70518-428170518-4281-00
Nortriptyline HydrochlorideNortriptyline hydrochloride 10 mg/1CapsuleOralCoupler LLC67046-150067046-1500-03

All 78 Nortriptyline Hydrochloride NDCs

Other NDCs under ANDA 075520

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

FDA NDC Directory listings under ANDA 075520
ProductStrengthForm · routeLabelerProduct NDC
Nortriptyline HydrochlorideNortriptyline hydrochloride 10 mg/1CapsuleOralA-S Medication Solutions50090-0537
Nortriptyline HydrochlorideNortriptyline hydrochloride 25 mg/1CapsuleOralNorthwind Health Company, LLC51655-507
Nortriptyline HydrochlorideNortriptyline hydrochloride 10 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.51672-4001
Nortriptyline HydrochlorideNortriptyline hydrochloride 25 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.51672-4002
Nortriptyline HydrochlorideNortriptyline hydrochloride 50 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.51672-4003
Nortriptyline HydrochlorideNortriptyline hydrochloride 75 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.51672-4004
Nortriptyline HydrochlorideNortriptyline hydrochloride 50 mg/1CapsuleOralDIRECT RX61919-353
Nortriptyline HydrochlorideNortriptyline hydrochloride 10 mg/1CapsuleOralProficient Rx LP63187-715
Nortriptyline HydrochlorideNortriptyline hydrochloride 50 mg/1CapsuleOralProficient Rx LP63187-798
Nortriptyline HydrochlorideNortriptyline hydrochloride 25 mg/1CapsuleOralNuCare Pharmaceuticals, Inc.68071-3211
Nortriptyline HydrochlorideNortriptyline hydrochloride 25 mg/1CapsuleOralBryant Ranch Prepack71335-0083
Nortriptyline HydrochlorideNortriptyline hydrochloride 50 mg/1CapsuleOralBryant Ranch Prepack71335-0155
Nortriptyline HydrochlorideNortriptyline hydrochloride 10 mg/1CapsuleOralBryant Ranch Prepack71335-0426
Nortriptyline HydrochlorideNortriptyline hydrochloride 75 mg/1CapsuleOralBryant Ranch Prepack71335-1552
Nortriptyline HydrochlorideNortriptyline hydrochloride 10 mg/1CapsuleOralNorthwind Health Company, LLC82868-023

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