Home NDC 43063-722-30 Nortriptyline Hydrochloride
Product NDC 43063-722
Requested package NDC 43063-722-30
11-digit product format 430630722
Labeler code 43063
Product ID 43063-722_414b1374-fc77-1888-e063-6394a90ad253
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nortriptyline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA073556
Marketing category ANDA
Marketing start 2016-06-01
Substance NORTRIPTYLINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A073556-001 NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 A073556-002 NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 A073556-003 NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 A073556-004 NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A073556-001 NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A073556-002 NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A073556-003 NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A073556-004 NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A073556-001 NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A073556-002 NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A073556-003 NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A073556-004 NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A073556-001 NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A073556-002 NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A073556-003 NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A073556-004 NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073556-001 NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073556-002 NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073556-003 NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073556-004 NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073556-001 NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073556-002 NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073556-003 NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073556-004 NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073556-001 NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073556-002 NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073556-003 NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073556-004 NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073556-001 NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073556-002 NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073556-003 NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073556-004 NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073556-001 NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073556-002 NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073556-003 NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073556-004 NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073556-001 NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073556-002 NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073556-003 NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073556-004 NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073556-001 NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 1992-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073556-002 NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL AB 1992-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073556-003 NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL AB 1992-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073556-004 NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1992-03-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nortriptyline Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORTRIPTYLINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 00FN6IH15D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 317136 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43063-722-30 Nortriptyline Hydrochloride 30 in 1 BOTTLE, PLASTIC CAPSULE 30 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-722 NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 1 package rows 20241016_ba4edb34-82ac-4c98-8abd-fd6176838c78.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 2 of 2 · 25 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nortriptyline Hydrochloride NORTRIPTYLINE HYDROCHLORIDE Advanced Rx Pharmacy of Tennessee, LLC 1a904ddf-574a-8a24-e063-6394a90aba3b 2024-06-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073556 application number: ANDA073556 Nortriptyline Hydrochloride NORTRIPTYLINE HYDROCHLORIDE Bryant Ranch Prepack 4442f029-dd5e-4834-9b01-eb8c638ce4b1 2024-02-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073556 application number: ANDA073556 Nortriptyline Hydrochloride NORTRIPTYLINE HYDROCHLORIDE Bryant Ranch Prepack 8811104b-6223-4ea6-a9c6-61d63a21b3cd 2024-02-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073556 application number: ANDA073556 Nortriptyline Hydrochloride NORTRIPTYLINE HYDROCHLORIDE Dr. Reddy's Laboratories Inc. b1d9582c-742c-91a8-c2b3-bbdb21220470 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073556 application number: ANDA073556 Nortriptyline Hydrochloride NORTRIPTYLINE HYDROCHLORIDE Mayne Pharma Inc. 765d726b-fd4b-4ef7-afd7-9e7e9bf8cae6 2021-03-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073556 application number: ANDA073556
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43063-722-30 43063072230 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-722-30) 30 capsule 2016-10-27 0000-00-00 No No Current