Home NDC 42023-224-01 Naloxone Hydrochloride
Product NDC 42023-224
Requested package NDC 42023-224-01
11-digit product format 420230224
Labeler code 42023
Product ID 42023-224_3b2e17da-1874-451c-80eb-1c87a62e585c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naloxone Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Par Health USA, LLC
Application ANDA215964
Marketing category ANDA
Marketing start 2024-11-05
Substance NALOXONE HYDROCHLORIDE
Active strength 1 mg/mL
Pharmacologic classes Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42023-224 42023-224-01 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215964-001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215964-001 AP
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 2026-02-19 14:30 UTC 2026-02 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 2022-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 2022-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 2022-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 2022-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 2022-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 2022-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215964-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-07-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Naloxone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NALOXONE HYDROCHLORIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F850569PQR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191250 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 42023-224-01 Naloxone Hydrochloride 1 in 1 CARTON INJECTION 1 21 42023-224-01 Naloxone Hydrochloride 2 mL in 1 SYRINGE, GLASS INJECTION 2 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-224 NALOXONE HYDROCHLORIDE INJECTION [ENDO USA, INC.] 20 Current NDC, 2 package rows 20241113_3ae08e26-223b-4971-b2f1-f1e183a3f930.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42023-224-01 42023022401 1 SYRINGE, GLASS in 1 CARTON (42023-224-01) / 2 mL in 1 SYRINGE, GLASS 2024-11-05 No No Current