Prescription drug · ANDA

Amitriptyline Hydrochloride NDC 72789-305

Amitriptyline hydrochloride 25 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)72789-305Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0305Add 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
72789-305-307278903053030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-305-30)Marketed from Mar 2, 2022

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)
Amitriptyline Hydrochloride
Generic name (nonproprietary)
amitriptyline hydrochloride
Active ingredients
Amitriptyline hydrochloride — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214548
Marketing start
Listing expires
Identifiers
Product ID 72789-305_4bbc12f8-bd28-29b4-e063-6394a90a2a25SPL ID 4bbc12f8-bd28-29b4-e063-6394a90a2a25SPL set ID 451b8742-8b3c-4335-9075-c1d8313cd3d0RxCUI 856834UNII 26LUD4JO9KUPC 0372789305301
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

N472789030530 followed by a unit qualifier and the quantity

Package 72789-0305-30. 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 For the relief of symptoms of depression. Endogenous depression is 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 72789-305

What is NDC 72789-305?
72789-305 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amitriptyline Hydrochloride.
What is the active ingredient?
Amitriptyline hydrochloride.
Who is the labeler?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amitriptyline Hydrochloride?
202 other product NDCs are listed under this name. See all Amitriptyline 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 Amitriptyline Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralCoupler LLC67046-068967046-0689-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-169467046-1694-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralCoupler LLC67046-167167046-1671-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-076467046-0764-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralCoupler LLC67046-166967046-1669-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-81859651-0818-0159651-0818-99
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-81959651-0819-0159651-0819-99
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-82059651-0820-01
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-82159651-0821-0159651-0821-60
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-82259651-0822-01

All 203 Amitriptyline Hydrochloride NDCs

Other NDCs under ANDA 214548

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

FDA NDC Directory listings under ANDA 214548
ProductStrengthForm · routeLabelerProduct NDC
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralAvPAK50268-041
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralAvPAK50268-039
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralAvPAK50268-040
Amitriptyline HCLAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralDirect_Rx72189-440
Amitriptyline HCLAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralDirect_Rx72189-444
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-693
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-696
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-694
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-695
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-697
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-698
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8218
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7513
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6179
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3979
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralCoupler LLC67046-0689
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9633
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9637
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9635
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0285

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