Home NDC 51662-1426 NALOXONE HYDROCHLORIDE
Product NDC 51662-1426
11-digit product format 516621426
Labeler code 51662
Product ID 51662-1426_2b38388a-7ffd-a3f9-e063-6394a90a3566
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NALOXONE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA207634
Marketing category ANDA
Marketing start 2020-01-10
Substance NALOXONE HYDROCHLORIDE
Active strength .4 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 44 .
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 A207634-001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207634-001 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.
Product history page 1 of 2 · 44 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 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 NALOXONE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NALOXONE HYDROCHLORIDE .4 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 1191222 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 51662-1426-1 NALOXONE HYDROCHLORIDE 10 mL in 1 VIAL, GLASS INJECTION, SOLUTION 10 3 51662-1426-1 NALOXONE HYDROCHLORIDE 1 in 1 CARTON INJECTION, SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1426 NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, Legacy NDC, 2 package rows 20250110_9bcff682-1196-7cef-e053-2a95a90aa954.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51662-1426-1 51662142601 1 VIAL, GLASS in 1 CARTON (51662-1426-1) / 10 mL in 1 VIAL, GLASS 2020-01-10 0000-00-00 No No Current