Prescription drug · ANDA

Amitriptyline Hydrochloride NDC 71335-2802

Amitriptyline hydrochloride 50 mg/1 · Tablet, Coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2802Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2802Add 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
71335-2802-17133528020171335280201100 TABLET, COATED in 1 BOTTLE (71335-2802-1)Marketed from Oct 3, 2025
71335-2802-2713352802027133528020230 TABLET, COATED in 1 BOTTLE (71335-2802-2)Marketed from Oct 3, 2025
71335-2802-3713352802037133528020360 TABLET, COATED in 1 BOTTLE (71335-2802-3)Marketed from Oct 3, 2025
71335-2802-4713352802047133528020490 TABLET, COATED in 1 BOTTLE (71335-2802-4)Marketed from Oct 3, 2025
71335-2802-5713352802057133528020520 TABLET, COATED in 1 BOTTLE (71335-2802-5)Marketed from Oct 3, 2025
71335-2802-6713352802067133528020628 TABLET, COATED in 1 BOTTLE (71335-2802-6)Marketed from Oct 3, 2025
71335-2802-7713352802077133528020756 TABLET, COATED in 1 BOTTLE (71335-2802-7)Marketed from Oct 3, 2025
71335-2802-87133528020871335280208180 TABLET, COATED in 1 BOTTLE (71335-2802-8)Marketed from Oct 3, 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)
Amitriptyline Hydrochloride
Generic name (nonproprietary)
amitriptyline hydrochloride
Active ingredients
Amitriptyline hydrochloride — 50 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212654
Marketing start
Listing expires
Identifiers
Product ID 71335-2802_b24ae4bb-d299-4a13-9cbe-6568dc4090cdSPL ID b24ae4bb-d299-4a13-9cbe-6568dc4090cdSPL set ID db4d83b8-3ce7-433e-b32a-a8dc2f44b909RxCUI 856845UNII 26LUD4JO9K
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

N471335280201 followed by a unit qualifier and the quantity

Package 71335-2802-01. 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 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 71335-2802

What is NDC 71335-2802?
71335-2802 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 50 mg/1 tablet, coated, listed with the FDA by Bryant Ranch Prepack. It has 8 package NDCs, 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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?
203 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 10 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-89660760-0896-15
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-169467046-1694-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralCoupler LLC67046-068967046-0689-03
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 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
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-82059651-0820-01
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-81859651-0818-0159651-0818-99

All 204 Amitriptyline Hydrochloride NDCs

Other NDCs under ANDA 212654

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

FDA NDC Directory listings under ANDA 212654
ProductStrengthForm · routeLabelerProduct NDC
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-077
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-078
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-079
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-080
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-081
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-082
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7271
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7273
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7424
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7599
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-8033
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralA-S Medication Solutions50090-8135
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1TabletOralA-S Medication Solutions50090-8136
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralSt. Mary's Medical Park Pharmacy60760-838
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-388
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-389
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-390
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-391
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-392
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-393

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