PHENYLEPHRINE HYDROCHLORIDE

Product NDC
71872-7273
Requested package NDC
71872-7273-1
11-digit product format
718727273
Labeler code
71872
Product ID
71872-7273_facbdcdc-e758-d7ef-e053-6394a90a7833
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA213318
Marketing category
ANDA
Marketing start
2021-09-22
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213318-001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11
A213318-002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11
A213318-003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A213318-001AP1
A213318-002AP1
A213318-003AP1

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 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213318-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213318-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213318-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12020-06-118072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213318-001AP11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213318-002AP11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213318-003AP11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213318-001AP1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213318-002AP1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213318-003AP1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213318-001AP116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213318-002AP116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213318-003AP116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213318-001AP11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213318-002AP11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213318-003AP11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213318-001AP11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213318-002AP11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213318-003AP11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213318-001AP1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213318-002AP1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213318-003AP1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213318-001AP112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213318-002AP112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213318-003AP112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213318-001AP115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213318-002AP115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213318-003AP115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213318-001AP11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213318-002AP11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213318-003AP11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213318-001AP11d06236e962d9…
2024-10-29 15:01 UTC2024-10A213318-002AP11d06236e962d9…
2024-10-29 15:01 UTC2024-10A213318-003AP11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213318-001AP1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213318-002AP1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213318-003AP1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213318-001AP11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213318-002AP11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213318-003AP11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213318-001AP111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213318-002AP111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213318-003AP111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213318-001AP118072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
PHENYLEPHRINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1666372Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d89d7004-e20a-0a35-e053-2a95a90a7b78Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7273-1PHENYLEPHRINE HYDROCHLORIDE1 in 1 BAGINJECTION12
71872-7273-1PHENYLEPHRINE HYDROCHLORIDE1 mL in 1 VIALINJECTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7273PHENYLEPHRINE HYDROCHLORIDE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230504_d89d7004-e20a-0a35-e053-2a95a90a7b78.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDECaplin Steriles Limited1b9f1d54-ea46-49c8-a33e-c94a61bc04602026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213318
application number: ANDA213318
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMedical Purchasing Solutions, LLC.41eec9e9-6e94-15d4-e063-6394a90a98a22025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213318
application number: ANDA213318
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESomerset Therapeutics, LLC18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e62023-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213318
application number: ANDA213318
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEMedical Purchasing Solutions, LLCd89d7004-e20a-0a35-e053-2a95a90a7b782023-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213318
application number: ANDA213318
ndc (package): 71872-7273-1
ndc (product): 71872-7273
ndc11 (package): 71872727301
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDEArmas Pharmaceuticals Inc.16c02d53-fd3f-4fd7-abbe-f1358ea0891f2023-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213318
application number: ANDA213318
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEXellia Pharmaceuticals USA LLCabd39d9c-fcda-4d01-8a58-1d54ba7ac6512021-11-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213318
application number: ANDA213318
PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDESomerset Therapeutics, LLC90a3853e-49d6-4536-be72-82cc875bcf742021-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213318
application number: ANDA213318

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNd89d7004-e20a-0a35-e053-2a95a90a7b782
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDd89d7004-e20a-0a35-e053-2a95a90a7b782
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYd89d7004-e20a-0a35-e053-2a95a90a7b782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71872-7273-1718727273011 VIAL in 1 BAG (71872-7273-1) / 1 mL in 1 VIAL1 vial2021-12-100000-00-00NoNoCurrent