Home NDC 70069-072 Naloxone Hydrochloride
Product NDC 70069-072
11-digit product format 700690072
Labeler code 70069
Product ID 70069-072_7a544942-0f60-4ed3-91df-049b7f74812e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naloxone Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Somerset Therapeutics, LLC
Application ANDA207634
Marketing category ANDA
Marketing start 2017-07-26
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 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 · 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 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…2022-10-28 04:53 UTC 2022-10 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207634-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-07-26 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 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 70069-072-01 Naloxone Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 9 70069-072-01 Naloxone Hydrochloride 10 mL in 1 VIAL, GLASS INJECTION, SOLUTION 10 9 70069-072-10 Naloxone Hydrochloride 10 in 1 BOX INJECTION, SOLUTION 10 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-072 NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] 9 Current NDC, Legacy NDC, 3 package rows 20231220_b59ee3cc-9604-4abc-81be-897e2f42aa67.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 NALOXONE HYDROCHLORIDE HF Acquisition Co. LLC. DBA HealthFirst 4d66b96a-acbb-2292-e063-6294a90af788 2026-03-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207634 application number: ANDA207634 Naloxone Hydrochloride NALOXONE HYDROCHLORIDE ProPharma Distribution 3f2bb95a-aeca-c0b7-e063-6394a90a627b 2025-09-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207634 application number: ANDA207634 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 9bcff682-1196-7cef-e053-2a95a90aa954 2025-01-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207634 application number: ANDA207634 Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Medical Purchasing Solutions, LLC 28f3e3bc-b1be-9f06-e063-6394a90a1936 2024-12-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207634 application number: ANDA207634 Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Somerset Therapeutics, LLC b59ee3cc-9604-4abc-81be-897e2f42aa67 2023-12-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 207634 application number: ANDA207634 ndc (product): 70069-072
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 70069-072-01 70069007201 1 in 1 CARTON Historical 70069-072-10 70069007210 10 CARTON in 1 BOX (70069-072-10) / 1 VIAL, GLASS in 1 CARTON (70069-072-01) / 10 mL in 1 VIAL, GLASS 10 carton 2017-07-26 0000-00-00 No No Current