FDA.reportPublic FDA data

Naloxone Hydrochloride

Product NDC
51316-210
11-digit product format
513160210
Labeler code
51316
Product ID
51316-210_3c18b06c-be22-4076-84f8-80610dda1e61
Type
HUMAN OTC DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
CVS Pharmacy, Inc
Application
ANDA217992
Marketing category
ANDA
Marketing start
2024-04-24
Substance
NALOXONE HYDROCHLORIDE
Active strength
4 mg/.1mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A217992-001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23

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 UTC2026-02A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-238072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Naloxone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALOXONE HYDROCHLORIDE4 mg/.1mL

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
1725059Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
840e017d-0142-4d0e-a80e-327ac44bc0c5Available 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
51316-210-01Naloxone Hydrochloride0.1 mL in 1 VIALSPRAY0.15
51316-210-02Naloxone Hydrochloride2 in 1 CARTONSPRAY25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-210NALOXONE HYDROCHLORIDE SPRAY [CVS PHARMACY, INC]3Current NDC, 2 package rows20240426_840e017d-0142-4d0e-a80e-327ac44bc0c5.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAvKARE1766a7f1-d301-945f-e063-6294a90ac6f42026-01-14WarningsExact identifier
application applno (ANDA): 217992
application number: ANDA217992
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAmneal Pharmaceuticals NY LLC8091a73d-9ecd-4578-a57b-5d85a2c5a16a2025-12-09WarningsExact identifier
application applno (ANDA): 217992
application number: ANDA217992
Naloxone HydrochlorideNALOXONE HYDROCHLORIDECVS Pharmacy, Inc840e017d-0142-4d0e-a80e-327ac44bc0c52024-04-24WarningsExact identifier
application applno (ANDA): 217992
application number: ANDA217992
ndc (product): 51316-210
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEWalgreen Co.3829826b-e48f-4e26-869f-6b9e4ee0a8402024-04-24WarningsExact identifier
application applno (ANDA): 217992
application number: ANDA217992
Naloxone HydrochlorideNALOXONEAmneal Pharmaceuticals NY LLC8779a073-dc6e-410a-9959-fd370f0079f92024-04-19WarningsExact identifier
application applno (ANDA): 217992
application number: ANDA217992

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN840e017d-0142-4d0e-a80e-327ac44bc0c55
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD840e017d-0142-4d0e-a80e-327ac44bc0c55
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY840e017d-0142-4d0e-a80e-327ac44bc0c55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-210-01513160210010.1 mL in 1 VIAL0.1 mlHistorical
51316-210-02513160210022 VIAL in 1 CARTON (51316-210-02) / .1 mL in 1 VIAL (51316-210-01) 2 vial2024-04-24NoNoCurrent