Home NDC 71872-7009 Naloxone Hydrochloride
Product NDC 71872-7009
11-digit product format 718727009
Labeler code 71872
Product ID 71872-7009_fa45551b-cd87-d4cc-e053-6294a90a8829
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nalxone Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Medical Purchasing Solutions, LLC
Application ANDA070299
Marketing category ANDA
Marketing start 1986-09-24
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 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 A070299-001 NALOXONE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070299-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070299-001 NALOXONE 0.4MG/ML INJECTABLE / INJECTION AP 1986-09-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 1659929 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 71872-7009-1 Naloxone Hydrochloride 1 mL in 1 VIAL INJECTION 1 2 71872-7009-1 Naloxone Hydrochloride 1 in 1 BAG INJECTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71872-7009 NALOXONE HYDROCHLORIDE (NALXONE HYDROCHLORIDE) INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20230427_8959171f-eda6-158c-e053-2995a90a36b2.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naloxone Hydrochloride NALXONE HYDROCHLORIDE Civica, Inc. 21d20dff-6efe-481e-a5a0-9c80ded73ca9 2026-06-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 070299 application number: ANDA070299 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 3ba53405-5e72-c035-e063-6294a90ac0b1 2025-08-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 070299 application number: ANDA070299 Naloxone Hydrochloride NALXONE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 1bef59b9-7d51-4f19-a054-44b8eb6c6398 2024-04-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 070299 application number: ANDA070299 Naloxone Hydrochloride NALXONE HYDROCHLORIDE Medical Purchasing Solutions, LLC 8959171f-eda6-158c-e053-2995a90a36b2 2023-04-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 070299 application number: ANDA070299 ndc (product): 71872-7009 Naloxone Hydrochloride NALXONE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 8cc25cf1-008c-4808-baec-49f35a887fae 2020-03-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 070299 application number: ANDA070299
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71872-7009-1 71872700901 1 VIAL in 1 BAG (71872-7009-1) / 1 mL in 1 VIAL 1 vial 2019-05-06 0000-00-00 No No Current