ZIMHI

Product NDC
84571-140
11-digit product format
845710140
Labeler code
84571
Product ID
84571-140_4525b96b-5ab9-b8fd-e063-6294a90aa699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
ZMI Pharma Inc.
Application
NDA212854
Marketing category
NDA
Marketing start
2022-01-15
Substance
NALOXONE HYDROCHLORIDE
Active strength
5 mg/.5mL
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N212854-001ZIMHINALOXONE HYDROCHLORIDE5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212854-001110270722039-05-24Drug product2022-06-06
N212854-001115715182041-06-14U-3515Drug product2023-02-10
N212854-001115715182041-06-14U-3516Drug product2023-02-10
N212854-001115715182041-06-14U-3517Drug product2023-02-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-153f0d92c62455…
2023-05-13 08:27 UTC2023-05N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15053a50430f4f…
2023-01-26 05:58 UTC2023-01N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212854-001ZIMHI5MG/0.5ML (5MG/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2021-10-15a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N212854-001110270722039-05-24Drug product2022-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212854-001115715182041-06-14U-3515Drug product2023-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212854-001115715182041-06-14U-3516Drug product2023-02-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212854-001115715182041-06-14U-3517Drug product2023-02-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212854-001110270722039-05-24Drug product2022-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212854-001115715182041-06-14U-3515Drug product2023-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212854-001115715182041-06-14U-3516Drug product2023-02-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212854-001115715182041-06-14U-3517Drug product2023-02-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N212854-001110270722039-05-24Drug product2022-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212854-001115715182041-06-14U-3515Drug product2023-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212854-001115715182041-06-14U-3516Drug product2023-02-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212854-001115715182041-06-14U-3517Drug product2023-02-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212854-001110270722039-05-24Drug product2022-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212854-001115715182041-06-14U-3515Drug product2023-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212854-001115715182041-06-14U-3516Drug product2023-02-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212854-001115715182041-06-14U-3517Drug product2023-02-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212854-001110270722039-05-24Drug product2022-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212854-001115715182041-06-14U-3515Drug product2023-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212854-001115715182041-06-14U-3516Drug product2023-02-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212854-001115715182041-06-14U-3517Drug product2023-02-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212854-001110270722039-05-24Drug product2022-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212854-001115715182041-06-14U-3515Drug product2023-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212854-001115715182041-06-14U-3516Drug product2023-02-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212854-001115715182041-06-14U-3517Drug product2023-02-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212854-001110270722039-05-24Drug product2022-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212854-001115715182041-06-14U-3515Drug product2023-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212854-001115715182041-06-14U-3516Drug product2023-02-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212854-001115715182041-06-14U-3517Drug product2023-02-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212854-001110270722039-05-24Drug product2022-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212854-001115715182041-06-14U-3515Drug product2023-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212854-001115715182041-06-14U-3516Drug product2023-02-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N212854-001115715182041-06-14U-3517Drug product2023-02-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212854-001110270722039-05-24Drug product2022-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212854-001115715182041-06-14U-3515Drug product2023-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212854-001115715182041-06-14U-3516Drug product2023-02-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N212854-001115715182041-06-14U-3517Drug product2023-02-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N212854-001110270722039-05-24Drug product2022-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N212854-001115715182041-06-14U-3515Drug product2023-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N212854-001115715182041-06-14U-3516Drug product2023-02-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N212854-001115715182041-06-14U-3517Drug product2023-02-10d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
ZIMHI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALOXONE HYDROCHLORIDE5 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F850569PQRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2589612Internal RxNorm lookup
2589618Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
523c0909-bff6-4010-988a-53de18b7cb3fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c955d208-c333-9bd7-be34-d7e12986d44eProduct name620250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304Product name120250204
caa6391e-3db3-c912-335f-61b5fc00aa12Product name920240110
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7dProduct name320230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
f327b80c-8fa2-404b-838a-df3eec141cf2Product name120221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119Product name120220511
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9Product name120211026
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84571-140-02ZIMHI1 in 1 CASEINJECTION, SOLUTION13
84571-140-02ZIMHI2 in 1 CARTONINJECTION, SOLUTION23
84571-140-11ZIMHI1 in 1 CARTONINJECTION, SOLUTION13
84571-140-11ZIMHI1 in 1 CASEINJECTION, SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84571-140ZIMHI (NALOXONE HYDROCHLORIDE) INJECTION, SOLUTION [ZMI PHARMA INC.]2Current NDC, 4 package rows20241123_523c0909-bff6-4010-988a-53de18b7cb3f.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZIMHINALOXONE HYDROCHLORIDEZMI Pharma Inc.523c0909-bff6-4010-988a-53de18b7cb3f2025-12-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 212854
application number: NDA212854
ndc (product): 84571-140

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2589612naloxone HCL 5 MG in 0.5 ML Prefilled SyringePSN523c0909-bff6-4010-988a-53de18b7cb3f3
2589618ZIMHI 5 MG in 0.5 ML Prefilled SyringePSN523c0909-bff6-4010-988a-53de18b7cb3f3
25896180.5 ML naloxone hydrochloride 10 MG/ML Prefilled Syringe [Zimhi]SBD523c0909-bff6-4010-988a-53de18b7cb3f3
25896120.5 ML naloxone hydrochloride 10 MG/ML Prefilled SyringeSCD523c0909-bff6-4010-988a-53de18b7cb3f3
2589612naloxone HCL 5 MG per 0.5 ML Prefilled SyringeSY523c0909-bff6-4010-988a-53de18b7cb3f3
2589618ZIMHI 5 MG per 0.5 ML Prefilled SyringeSY523c0909-bff6-4010-988a-53de18b7cb3f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84571-140-02845710140022 CASE in 1 CARTON (84571-140-02) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE2 case2022-01-15NoNoCurrent
84571-140-11845710140111 CASE in 1 CARTON (84571-140-11) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE1 case2022-01-15NoNoCurrent