Home NDC 0406-9911 PAMELOR
Product NDC 0406-9911
11-digit product format 004069911
Labeler code 0406
Product ID 0406-9911_0c3b20b3-e852-4959-815a-90ed989a30e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nortriptyline hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler SpecGx LLC
Application NDA018013
Marketing category NDA
Marketing start 1977-08-01
Marketing end 2027-11-30
Substance NORTRIPTYLINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N018013-001 PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE CAPSULE / ORAL RLD, Approved before 1982 N018013-002 PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE CAPSULE / ORAL RLD, Approved before 1982 N018013-003 PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL RLD, Approved before 1982 N018013-004 PAMELOR NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL RLD, Approved before 1982
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.
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 2026-08-01 22:54:32 2026-06 N018013-001 PAMELOR EQ 10MG BASE CAPSULE / ORAL RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N018013-002 PAMELOR EQ 25MG BASE CAPSULE / ORAL RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N018013-003 PAMELOR EQ 75MG BASE CAPSULE / ORAL RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N018013-004 PAMELOR EQ 50MG BASE CAPSULE / ORAL RLD, Approved before 1982 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAMELOR NORTRIPTYLINE HYDROCHLORIDE SpecGx LLC e17dc299-f52d-414d-ab6e-e809bd6f8acb 2024-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018013 application number: NDA018013 ndc (product): 0406-9911
Additional Listing Data#
Finished product Yes
Brand name base PAMELOR 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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198045 Internal RxNorm lookup 198046 Internal RxNorm lookup 198047 Internal RxNorm lookup 209329 Internal RxNorm lookup 209339 Internal RxNorm lookup 209350 Internal RxNorm lookup 209391 Internal RxNorm lookup 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 0406-9911-03 PAMELOR 30 in 1 BOTTLE CAPSULE 30 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NORTRIPTYLINE HYDROCHLORIDE ACTIVE INGREDIENT 00FN6IH15D PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 14 NORTRIPTYLINE ACTIVE MOIETY BL03SY4LXB PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 14 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 14 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 14 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 14 GELATIN INACTIVE INGREDIENT 2G86QN327L PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 14 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-9911 PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) CAPSULE [SPECGX LLC] 23 Current NDC, Legacy NDC, 1 package rows 20241208_e17dc299-f52d-414d-ab6e-e809bd6f8acb.zip
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 0406-9911-03 00406991103 30 CAPSULE in 1 BOTTLE (0406-9911-03) 30 capsule 1977-08-01 2027-11-30 No No Current