FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
0781-3458
Requested package NDC
0781-3458-95
11-digit product format
007813458
Labeler code
0781
Product ID
0781-3458_14eec16d-4652-44a3-8cd3-a37b4280deb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA208905
Marketing category
ANDA
Marketing start
2020-01-15
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
A208905-001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31
A208905-002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31
A208905-003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208905-001AP1
A208905-002AP1
A208905-003AP1

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP1RS2019-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208905-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP12019-01-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208905-001AP11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208905-002AP11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208905-003AP11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-001AP1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-002AP1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208905-003AP1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208905-001AP116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208905-002AP116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208905-003AP116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-001AP11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-002AP11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208905-003AP11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-001AP11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-002AP11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208905-003AP11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-001AP1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-002AP1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208905-003AP1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-001AP112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-002AP112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208905-003AP112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-001AP115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-002AP115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208905-003AP115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-001AP11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-002AP11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208905-003AP11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208905-001AP11d06236e962d9…
2024-10-29 15:01 UTC2024-10A208905-002AP11d06236e962d9…
2024-10-29 15:01 UTC2024-10A208905-003AP11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-001AP1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-002AP1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208905-003AP1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-001AP11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-002AP11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208905-003AP11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-001AP111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-002AP111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208905-003AP111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208905-001AP118072bd15b7f6…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1232651Internal RxNorm lookup
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
6feb2da2-05ef-47bb-9d8d-01b81ad69059Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3458-75Phenylephrine Hydrochloride5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION520
0781-3458-95Phenylephrine Hydrochloride10 in 1 CARTONINJECTION1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3458-75ML - Milliliter0781-3458716d11d4-d173-4127-bbf0-12f30b13ab4012020-06-05
0781-3458-95ML - Milliliter0781-3458760510a9-386b-4aae-acf8-f51304249e8a12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3458PHENYLEPHRINE HYDROCHLORIDE INJECTION [SANDOZ INC]19Current NDC, Legacy NDC, 2 package rows20221018_6feb2da2-05ef-47bb-9d8d-01b81ad69059.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESandoz Inc5788f8c6-f868-4b83-81dc-dc485d8716c02022-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208905
application number: ANDA208905
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDESandoz Inc6feb2da2-05ef-47bb-9d8d-01b81ad690592022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208905
application number: ANDA208905
ndc (package): 0781-3458-95
ndc (product): 0781-3458
ndc11 (package): 00781345895

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN6feb2da2-05ef-47bb-9d8d-01b81ad6905920
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSN6feb2da2-05ef-47bb-9d8d-01b81ad6905920
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD6feb2da2-05ef-47bb-9d8d-01b81ad6905920
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCD6feb2da2-05ef-47bb-9d8d-01b81ad6905920
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY6feb2da2-05ef-47bb-9d8d-01b81ad6905920
1232651phenylephrine hydrochloride 1 % Injectable SolutionSY6feb2da2-05ef-47bb-9d8d-01b81ad6905920
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSY6feb2da2-05ef-47bb-9d8d-01b81ad6905920
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSY6feb2da2-05ef-47bb-9d8d-01b81ad6905920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3458-950078134589510 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3458-95) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0781-3458-75) 2020-01-150000-00-00NoNoCurrent