Home NDC 67457-645 Naloxone Hydrochloride
Product NDC 67457-645
11-digit product format 674570645
Labeler code 67457
Product ID 67457-645_ae19fec7-aac8-4fbe-a2aa-ba18a3fe5c9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name naloxone hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Mylan Institutional LLC
Application ANDA204997
Marketing category ANDA
Marketing start 2020-01-24
Marketing end 0000-00-00
Substance NALOXONE HYDROCHLORIDE
Active strength 0 mg/mL
Pharmacologic classes Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A204997-001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204997-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204997-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2014-03-06 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-645 NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 2 Legacy NDC 20210427_5adbf891-4d73-4026-98b1-174783d68c9a.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67457-645-02 67457064502 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-645-02) > 1 mL in 1 VIAL, SINGLE-DOSE (67457-645-00) 2020-01-24 0000-00-00 No No Current