Home NDC 0409-1215 Naloxone Hydrochloride
Product NDC 0409-1215
11-digit product format 004091215
Labeler code 0409
Product ID 0409-1215_2b456953-1487-4550-946e-50c01536c8ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NALOXONE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Hospira, Inc.
Application ANDA070256
Marketing category ANDA
Marketing start 2005-07-12
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 A070256-001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070256-001 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 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070256-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP RS 1987-01-07 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 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1191222 Internal RxNorm lookup 1659929 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 0409-1215-01 Naloxone Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 35 0409-1215-21 Naloxone Hydrochloride 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 35
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NALOXONE HYDROCHLORIDE ACTIVE INGREDIENT F850569PQR NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 NALOXONE ACTIVE MOIETY 36B82AMQ7N NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 WATER INACTIVE INGREDIENT 059QF0KO0R NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 12 NALOXONE HYDROCHLORIDE ACTIVE INGREDIENT F850569PQR NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 3 NALOXONE ACTIVE MOIETY 36B82AMQ7N NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 3 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 3 WATER INACTIVE INGREDIENT 059QF0KO0R NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH] 3 NALOXONE HYDROCHLORIDE ACTIVE INGREDIENT F850569PQR NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 NALOXONE ACTIVE MOIETY 36B82AMQ7N NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1215 NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 34 Current NDC, Legacy NDC, 2 package rows 20250124_8535cc84-ad4a-4d67-8480-fb5a2e3406f8.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.
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 0409-1215-01 00409121501 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1215-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1215-21) 2005-07-12 0000-00-00 No No Current 0409-1215-21 00409121521 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical