FDA.reportPublic FDA data

PHENYLEPHRINE HYDROCHLORIDE

Product NDC
72205-265
Requested package NDC
72205-265-07
11-digit product format
722050265
Labeler code
72205
Product ID
72205-265_0bb7af81-62ec-4ae7-8055-89453f7a161d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA217521
Marketing category
ANDA
Marketing start
2023-07-10
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
A217521-001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26
A217521-002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26
A217521-003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217521-001AP2
A217521-002AP2
A217521-003AP2

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 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217521-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217521-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217521-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUSAP22023-06-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217521-001AP21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217521-002AP21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217521-003AP21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217521-001AP2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217521-002AP2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217521-003AP2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217521-001AP216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217521-002AP216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217521-003AP216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217521-001AP21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217521-002AP21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217521-003AP21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217521-001AP21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217521-002AP21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217521-003AP21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217521-001AP2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217521-002AP2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217521-003AP2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217521-001AP212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217521-002AP212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217521-003AP212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217521-001AP215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217521-002AP215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217521-003AP215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217521-001AP21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217521-002AP21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217521-003AP21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217521-001AP21d06236e962d9…
2024-10-29 15:01 UTC2024-10A217521-002AP21d06236e962d9…
2024-10-29 15:01 UTC2024-10A217521-003AP21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217521-001AP2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217521-002AP2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217521-003AP2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217521-001AP21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217521-002AP21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217521-003AP21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217521-001AP211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217521-002AP211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217521-003AP211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217521-001AP218072bd15b7f6…

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
0bb7af81-62ec-4ae7-8055-89453f7a161dAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-265-01PHENYLEPHRINE HYDROCHLORIDE5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION51
72205-265-07PHENYLEPHRINE HYDROCHLORIDE10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-265-01ML - Milliliter72205-26500227242-2de8-4935-b181-9e317ce52a7012024-07-12
72205-265-07ML - Milliliter72205-2651a76969c-d04c-483d-8649-832fd5a68dee12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-265PHENYLEPHRINE HYDROCHLORIDE INJECTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 2 package rows20240507_0bb7af81-62ec-4ae7-8055-89453f7a161d.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 HYDROCHLORIDENovadoz Pharmaceuticals LLC0bb7af81-62ec-4ae7-8055-89453f7a161d2023-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217521
application number: ANDA217521
ndc (package): 72205-265-07
ndc (product): 72205-265
ndc11 (package): 72205026507
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEBE Pharmaceuticals Inc.fb069778-d16e-40f9-9c02-5496adfcb5d22023-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217521
application number: ANDA217521

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN0bb7af81-62ec-4ae7-8055-89453f7a161d1
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSN0bb7af81-62ec-4ae7-8055-89453f7a161d1
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD0bb7af81-62ec-4ae7-8055-89453f7a161d1
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCD0bb7af81-62ec-4ae7-8055-89453f7a161d1
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY0bb7af81-62ec-4ae7-8055-89453f7a161d1
1232651phenylephrine hydrochloride 1 % Injectable SolutionSY0bb7af81-62ec-4ae7-8055-89453f7a161d1
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSY0bb7af81-62ec-4ae7-8055-89453f7a161d1
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSY0bb7af81-62ec-4ae7-8055-89453f7a161d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-265-077220502650710 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72205-265-07) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (72205-265-01) 2024-05-04NoNoCurrent