FDA.reportPublic FDA data

Naloxone Hydrochloride

Product NDC
71288-814
11-digit product format
712880814
Labeler code
71288
Product ID
71288-814_cedd8237-fb6c-48a4-81da-156d09b01943
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA214211
Marketing category
ANDA
Marketing start
2026-01-01
Marketing end
2026-06-01
Substance
NALOXONE HYDROCHLORIDE
Active strength
.4 mg/mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71288-814DDiscontinued by firm2026-08-11
excluded packagepackage71288-81471288-814-81DDiscontinued by firm2026-08-11

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
A214211-001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2025-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214211-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214211-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2025-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214211-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2025-08-2131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214211-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2025-08-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214211-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214211-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214211-001AP1a50c72e98297…

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
71288-814-81Naloxone Hydrochloride1 mL in 1 SYRINGEINJECTION12
71288-814-81Naloxone Hydrochloride10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-814-81ML - Milliliter71288-814f0907ae4-fa7b-45fe-8020-6cbdd4eeea3312026-01-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-814-817128808148110 SYRINGE in 1 CARTON (71288-814-81) / 1 mL in 1 SYRINGE10 syringe2026-01-012026-06-01NoNoHistorical