NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2397Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2397Add 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
71335-2397-07133523970071335239700120 TABLET in 1 BOTTLE (71335-2397-0)Marketed from May 29, 2024
71335-2397-1713352397017133523970120 TABLET in 1 BOTTLE (71335-2397-1)Marketed from May 29, 2024
71335-2397-2713352397027133523970230 TABLET in 1 BOTTLE (71335-2397-2)Marketed from May 29, 2024
71335-2397-37133523970371335239703100 TABLET in 1 BOTTLE (71335-2397-3)Marketed from May 29, 2024
71335-2397-4713352397047133523970460 TABLET in 1 BOTTLE (71335-2397-4)Marketed from May 29, 2024
71335-2397-5713352397057133523970550 TABLET in 1 BOTTLE (71335-2397-5)Marketed from May 29, 2024
71335-2397-6713352397067133523970690 TABLET in 1 BOTTLE (71335-2397-6)Marketed from May 29, 2024
71335-2397-7713352397077133523970745 TABLET in 1 BOTTLE (71335-2397-7)Marketed from May 29, 2024
71335-2397-8713352397087133523970828 TABLET in 1 BOTTLE (71335-2397-8)Marketed from May 29, 2024
71335-2397-9713352397097133523970956 TABLET in 1 BOTTLE (71335-2397-9)Marketed from May 29, 2024

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 — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217411
Marketing start
Listing expires
Identifiers
Product ID 71335-2397_59d04648-11e9-482b-90e7-d31d6e8703c5SPL ID 59d04648-11e9-482b-90e7-d31d6e8703c5SPL set ID a726f82c-1018-44ee-ab1f-f5d34e6b388eRxCUI 856834UNII 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

N471335239700 followed by a unit qualifier and the quantity

Package 71335-2397-00. 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 71335-2397

What is NDC 71335-2397?
71335-2397 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 25 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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 217411

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

FDA NDC Directory listings under ANDA 217411
ProductStrengthForm · routeLabelerProduct NDC
Amitriptyline HCLAmitriptyline hydrochloride 100 mg/1TabletOralDirect_rx72189-581
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralMajor Pharmaceuticals0904-7410
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralMajor Pharmaceuticals0904-7411
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1TabletOralRising Pharma Holdings, Inc.16571-105
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralRising Pharma Holdings, Inc.16571-106
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralRising Pharma Holdings, Inc.16571-107
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1TabletOralRising Pharma Holdings, Inc.16571-108
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralRising Pharma Holdings, Inc.16571-109
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1TabletOralRising Pharma Holdings, Inc.16571-110
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralA-S Medication Solutions50090-7583
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralA-S Medication Solutions50090-7598
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-685
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-686
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-732
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3656
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4052
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8691
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8767
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8788
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralREMEDYREPACK INC.70518-4048

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