Home NDC 54288-124 Naloxone Hydrochloride
Product NDC 54288-124
11-digit product format 542880124
Labeler code 54288
Product ID 54288-124_f0223f84-ddc4-45a8-94e8-22cd1a39f19e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naloxone Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler BPI Labs LLC
Application ANDA216977
Marketing category ANDA
Marketing start 2023-11-15
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 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 A216977-001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216977-001 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 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216977-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2023-10-06 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54288-124 NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [BPI LABS LLC] 3 Current NDC 20250213_5de44ee7-6525-4857-9a67-8882e96dbeb5.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 Units Marketing start Sample Exclude flag Status 54288-124-01 54288012401 1 PACKAGE in 1 CARTON (54288-124-01) / 2 mL in 1 PACKAGE 1 package 2023-11-15 No No Current 54288-124-10 54288012410 10 PACKAGE in 1 CARTON (54288-124-10) / 2 mL in 1 PACKAGE 10 package 2023-11-15 No No Current