Home NDC 78670-140 Zimhi
Product NDC 78670-140
11-digit product format 786700140
Labeler code 78670
Product ID 78670-140_98dc3cf1-2f05-4619-a6df-6c46c16e7af1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NALOXONE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler USWM, LLC
Application NDA212854
Marketing category NDA
Marketing start 2022-03-31
Marketing end 0000-00-00
Substance NALOXONE HYDROCHLORIDE
Active strength 5 mg/.5mL
Pharmacologic classes Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 78670-140 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 78670-140 78670-140-02 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 N212854-001 ZIMHI NALOXONE HYDROCHLORIDE 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212854-001 11027072 2039-05-24 Drug product 2022-06-06 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10
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 2026-02-19 14:30 UTC 2026-02 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212854-001 ZIMHI 5MG/0.5ML (5MG/0.5ML) SOLUTION / INTRAMUSCULAR, SUBCUTANEOUS RLD, RS 2021-10-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 98 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N212854-001 11027072 2039-05-24 Drug product 2022-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212854-001 11027072 2039-05-24 Drug product 2022-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212854-001 11027072 2039-05-24 Drug product 2022-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212854-001 11027072 2039-05-24 Drug product 2022-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212854-001 11027072 2039-05-24 Drug product 2022-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212854-001 11027072 2039-05-24 Drug product 2022-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212854-001 11027072 2039-05-24 Drug product 2022-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212854-001 11027072 2039-05-24 Drug product 2022-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212854-001 11027072 2039-05-24 Drug product 2022-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212854-001 11027072 2039-05-24 Drug product 2022-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212854-001 11571518 2041-06-14 U-3515 Drug product 2023-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212854-001 11571518 2041-06-14 U-3516 Drug product 2023-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212854-001 11571518 2041-06-14 U-3517 Drug product 2023-02-10 d06236e962d9…
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78670-140 ZIMHI (NALOXONE HYDROCHLORIDE) INJECTION, SOLUTION [USWM, LLC] 7 Legacy NDC 20240621_52e49022-9172-4da3-ba83-5995cacca9fb.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZIMHI NALOXONE HYDROCHLORIDE ZMI Pharma Inc. 523c0909-bff6-4010-988a-53de18b7cb3f 2025-12-04 Warnings, Adverse reactions Exact identifier application applno (NDA): 212854 application number: NDA212854
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 78670-140-02 78670014002 2 SYRINGE in 1 CARTON (78670-140-02) > .5 mL in 1 SYRINGE (78670-140-11) 2 syringe 2022-03-15 0000-00-00 No No Current