Primatene Mist

Product NDC
17270-5530
11-digit product format
172705530
Labeler code
17270
Product ID
17270-5530_5bb16a0a-5502-4279-b7ed-e333a1edaaf1
Type
HUMAN OTC DRUG
Nonproprietary name
Epinephrine Inhalation
Dosage form
AEROSOL
Route
RESPIRATORY (INHALATION)
Labeler
Armstrong Pharmaceuticals, Inc.
Application
NDA205920
Marketing category
NDA
Marketing start
2018-12-14
Substance
EPINEPHRINE
Active strength
125 ug/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
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
N205920-001PRIMATENE MISTEPINEPHRINE0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205920-00183677342026-01-26Drug product2018-12-17

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 UTC2026-02N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-073f01610625f2…
2019-09-15 20:21 UTC2019-09N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N205920-001PRIMATENE MIST0.125MG/INHAEROSOL, METERED / INHALATIONRLD, RS2018-11-07cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N205920-00183677342026-01-26Drug product2018-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205920-00183677342026-01-26Drug product2018-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N205920-00183677342026-01-26Drug product2018-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205920-00183677342026-01-26Drug product2018-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205920-00183677342026-01-26Drug product2018-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205920-00183677342026-01-26Drug product2018-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205920-00183677342026-01-26Drug product2018-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205920-00183677342026-01-26Drug product2018-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205920-00183677342026-01-26Drug product2018-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205920-00183677342026-01-26Drug product2018-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205920-00183677342026-01-26Drug product2018-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205920-00183677342026-01-26Drug product2018-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205920-00183677342026-01-26Drug product2018-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205920-00183677342026-01-26Drug product2018-12-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205920-00183677342026-01-26Drug product2018-12-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205920-00183677342026-01-26Drug product2018-12-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205920-00183677342026-01-26Drug product2018-12-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205920-00183677342026-01-26Drug product2018-12-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205920-00183677342026-01-26Drug product2018-12-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205920-00183677342026-01-26Drug product2018-12-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205920-00183677342026-01-26Drug product2018-12-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N205920-00183677342026-01-26Drug product2018-12-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205920-00183677342026-01-26Drug product2018-12-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205920-00183677342026-01-26Drug product2018-12-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205920-00183677342026-01-26Drug product2018-12-173f01610625f2…
2019-09-15 20:21 UTC2019-09N205920-00183677342026-01-26Drug product2018-12-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N205920-00183677342026-01-26Drug product2018-12-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205920-00183677342026-01-26Drug product2018-12-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205920-00183677342026-01-26Drug product2018-12-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205920-00183677342026-01-26Drug product2018-12-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205920-00183677342026-01-26Drug product2018-12-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205920-00183677342026-01-26Drug product2018-12-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205920-00183677342026-01-26Drug product2018-12-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205920-00183677342026-01-26Drug product2018-12-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N205920-00183677342026-01-26Drug product2018-12-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N205920-00183677342026-01-26Drug product2018-12-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205920-00183677342026-01-26Drug product2018-12-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205920-00183677342026-01-26Drug product2018-12-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205920-00183677342026-01-26Drug product2018-12-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N205920-00183677342026-01-26Drug product2018-12-17cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N205920-001NP2021-11-0774a2ff9319b5…
2021-12-28 21:50 UTC2021-12N205920-001NP2021-11-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205920-001NP2021-11-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N205920-001NP2021-11-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205920-001NP2021-11-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205920-001NP2021-11-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205920-001NP2021-11-073f01610625f2…
2019-09-15 20:21 UTC2019-09N205920-001NP2021-11-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N205920-001NP2021-11-07ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Primatene Mist
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE125 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YKH834O4BHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2109083Internal RxNorm lookup
2109088Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
95011f7e-51be-4851-80a6-a7e9c6cad82aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17270-5530-0Primatene Mist1 in 1 CARTONAEROSOL15
17270-5530-0Primatene Mist160 in 1 INHALERAEROSOL1605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17270-5530PRIMATENE MIST (EPINEPHRINE INHALATION) AEROSOL [ARMSTRONG PHARMACEUTICALS, INC.]5Current NDC, 2 package rows20240820_95011f7e-51be-4851-80a6-a7e9c6cad82a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Primatene MistEPINEPHRINE INHALATIONArmstrong Pharmaceuticals, Inc.95011f7e-51be-4851-80a6-a7e9c6cad82a2026-06-16WarningsExact identifier
application applno (NDA): 205920
application number: NDA205920
ndc (product): 17270-5530

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2109083EPINEPHrine 0.125 MG/ACTUAT in 160 ACTUAT Metered Dose InhalerPSN95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109088Primatene MIST 0.125 MG/ACTUAT in 160 ACTUAT Metered Dose InhalerPSN95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109088160 ACTUAT epinephrine 0.125 MG/ACTUAT Metered Dose Inhaler [Primatene Mist Inhaler]SBD95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109083160 ACTUAT epinephrine 0.125 MG/ACTUAT Metered Dose InhalerSCD95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109088160 ACTUAT Primatene Mist Inhaler 0.125 MG/ACTUAT Metered Dose InhalerSY95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109083epinephrine 0.125 MG/ACTUAT per 160 ACTUAT Metered Dose InhalerSY95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109088Primatene Mist 0.125 MG/ACTUAT per 160 ACTUAT Metered Dose InhalerSY95011f7e-51be-4851-80a6-a7e9c6cad82a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17270-5530-0172705530001 INHALER in 1 CARTON (17270-5530-0) / 160 AEROSOL in 1 INHALER1 inhaler2018-12-14NoNoCurrent