Home NDC 76045-112-20 Naloxone Hydrochloride
Product NDC 76045-112
Requested package NDC 76045-112-20
11-digit product format 760450112
Labeler code 76045
Product ID 76045-112_6503f42d-3303-497a-9653-4b6d89bf7833
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NALOXONE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA213573
Marketing category ANDA
Marketing start 2024-04-02
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213573-001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 A213573-002 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 2026-09-14 22:38:34 2026-08 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213573-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2024-04-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213573-002 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2024-04-02 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191250 Internal RxNorm lookup 2679504 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 76045-112-01 Naloxone Hydrochloride 2 mL in 1 SYRINGE INJECTION, SOLUTION 2 5 76045-112-20 Naloxone Hydrochloride 24 in 1 CASE INJECTION, SOLUTION 24 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76045-112 NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 4 Current NDC, 2 package rows 20240802_201fdedf-1736-4e52-9d7d-de14292547fd.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 76045-112-20 76045011220 24 SYRINGE in 1 CASE (76045-112-20) / 2 mL in 1 SYRINGE (76045-112-01) 24 syringe 2024-04-02 No No Current