Home NDC 71839-129-10 Phenylephrine Hydrochloride
Product NDC 71839-129
Requested package NDC 71839-129-10
11-digit product format 718390129
Labeler code 71839
Product ID 71839-129_fb069778-d16e-40f9-9c02-5496adfcb5d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenylephrine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler BE Pharmaceuticals Inc.
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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217521-001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 A217521-002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 A217521-003 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 69 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217521-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217521-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217521-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP2 2023-06-26 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Phenylephrine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1232651 Internal RxNorm lookup 1666372 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71839-129-01 Phenylephrine Hydrochloride 10 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION 10 1 71839-129-10 Phenylephrine Hydrochloride 10 in 1 CARTON INJECTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71839-129 PHENYLEPHRINE HYDROCHLORIDE INJECTION [BE PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20230710_fb069778-d16e-40f9-9c02-5496adfcb5d2.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71839-129-10 71839012910 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71839-129-10) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (71839-129-01) 2023-07-10 No No Current