Naloxone Hydrochloride

Product NDC
76329-3369
11-digit product format
763293369
Labeler code
76329
Product ID
76329-3369_2db33194-380a-4dd5-ba87-abdad14209bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
INJECTION
Route
PARENTERAL
Labeler
International Medication Systems, Limited
Application
ANDA072076
Marketing category
ANDA
Marketing start
2001-06-01
Substance
NALOXONE HYDROCHLORIDE
Active strength
1 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072076-001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A072076-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS1988-03-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS1988-03-243f01610625f2…
2019-09-15 20:21 UTC2019-09A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS1988-03-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONRS1988-03-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072076-001NALOXONE HYDROCHLORIDE1MG/MLINJECTABLE / INJECTIONAPRS1988-03-24cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A072076-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072076-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072076-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072076-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072076-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072076-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072076-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072076-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072076-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072076-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072076-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072076-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072076-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072076-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072076-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072076-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072076-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A072076-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072076-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072076-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A072076-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072076-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072076-001AP1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072076-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072076-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072076-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072076-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072076-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072076-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072076-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072076-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072076-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072076-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072076-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072076-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072076-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A072076-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALOXONE HYDROCHLORIDE1 mg/mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1191250Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
236349ef-2cb5-47ca-a3a5-99534c3a4996Available 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
76329-3369-1Naloxone Hydrochloride2 mL in 1 SYRINGEINJECTION27
76329-3369-1Naloxone Hydrochloride10 in 1 BOXINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-3369-1ML - Milliliter76329-3369d625d3e0-0ffe-4701-b3d8-177b7de5ef4c12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-3369NALOXONE HYDROCHLORIDE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]7Current NDC, Legacy NDC, 2 package rows20241222_236349ef-2cb5-47ca-a3a5-99534c3a4996.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Incbd65e3fe-cd7a-4855-8f55-8cc3a0921ccc2026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072076
application number: ANDA072076
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEREMEDYREPACK INC.68df290c-d776-4cfc-9565-332eb56c47232026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072076
application number: ANDA072076
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEInternational Medication Systems, Limited236349ef-2cb5-47ca-a3a5-99534c3a49962024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072076
application number: ANDA072076
ndc (product): 76329-3369
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC, DBA HealthFirst74fc593e-ed47-efae-e053-2991aa0a59972024-01-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072076
application number: ANDA072076
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLC958577c3-d2c4-26ad-e053-2a95a90ad73a2023-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072076
application number: ANDA072076
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEMedical Purchasing Solutions, LLCea4ea2fe-af48-0b3c-e053-2a95a90a0ad52023-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072076
application number: ANDA072076
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEInternational Medication Systems, Limitedd2f5bfa0-933e-46d0-8b1a-9f90e6aaba542021-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072076
application number: ANDA072076

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSNbd65e3fe-cd7a-4855-8f55-8cc3a0921ccc10
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCDbd65e3fe-cd7a-4855-8f55-8cc3a0921ccc10
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSYbd65e3fe-cd7a-4855-8f55-8cc3a0921ccc10
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSN68df290c-d776-4cfc-9565-332eb56c47238
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCD68df290c-d776-4cfc-9565-332eb56c47238
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSY68df290c-d776-4cfc-9565-332eb56c47238
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSN236349ef-2cb5-47ca-a3a5-99534c3a49967
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCD236349ef-2cb5-47ca-a3a5-99534c3a49967
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSY236349ef-2cb5-47ca-a3a5-99534c3a49967
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSN74fc593e-ed47-efae-e053-2991aa0a59976
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCD74fc593e-ed47-efae-e053-2991aa0a59976
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSY74fc593e-ed47-efae-e053-2991aa0a59976
1191250naloxone HCl 2 MG in 2 ML Prefilled SyringePSN958577c3-d2c4-26ad-e053-2a95a90ad73a2
11912502 ML naloxone hydrochloride 1 MG/ML Prefilled SyringeSCD958577c3-d2c4-26ad-e053-2a95a90ad73a2
1191250naloxone hydrochloride 2 MG per 2 ML Prefilled SyringeSY958577c3-d2c4-26ad-e053-2a95a90ad73a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76329-3369-17632933690110 SYRINGE in 1 BOX (76329-3369-1) / 2 mL in 1 SYRINGE10 syringe2001-06-010000-00-00NoNoCurrent