Home NDC 51662-1690 NALOXONE HYDROCHLORIDE
Product NDC 51662-1690
11-digit product format 516621690
Labeler code 51662
Product ID 51662-1690_53ff9b83-0e45-67e4-e063-6294a90aed3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NALOXONE HYDROCHLORIDE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA213209
Marketing category ANDA
Marketing start 2020-03-18
Substance NALOXONE HYDROCHLORIDE
Active strength 1 mg/mL
Pharmacologic classes Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213209-001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213209-001 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 2026-09-14 22:38:34 2026-08 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213209-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2020-03-16 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2020-12-22 03:56 UTC 2020-12 A213209-001 CGT 2020-09-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213209-001 CGT 2020-09-14 c0c555d07b60…
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 2027-12-31 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.
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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51662-1690-3 51662169003 10 POUCH in 1 CASE (51662-1690-3) / 1 BOX in 1 POUCH (51662-1690-2) / 1 SYRINGE in 1 BOX (51662-1690-1) / 2 mL in 1 SYRINGE 10 pouch 2020-03-18 No No Current