Home NDC 71872-7231-1 Phenylephrine hydrochloride
Product NDC 71872-7231
Requested package NDC 71872-7231-1
11-digit product format 718727231
Labeler code 71872
Product ID 71872-7231_b6354af6-687c-b131-e053-2995a90a1b15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenylephrine hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Medical Purchasing Solutions, LLC
Application ANDA211081
Marketing category ANDA
Marketing start 2020-08-12
Marketing end 0000-00-00
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record
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 A211081-001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 A211081-002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 A211081-003 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17
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 3 · 117 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 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211081-002 PHENYLEPHRINE HYDROCHLORIDE 50MG/5ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211081-003 PHENYLEPHRINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211081-001 PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS AP1 2020-07-17 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71872-7231-1 Phenylephrine hydrochloride 1 in 1 BAG INJECTION 1 2 71872-7231-1 Phenylephrine hydrochloride 1 mL in 1 VIAL INJECTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71872-7231 PHENYLEPHRINE HYDROCHLORIDE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC] 2 Legacy NDC, 2 package rows 20230505_b6358e7a-ecd5-dad5-e053-2995a90aac3f.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 Units Marketing start Marketing end Sample Exclude flag Status 71872-7231-1 71872723101 1 VIAL in 1 BAG (71872-7231-1) > 1 mL in 1 VIAL 1 vial 2020-11-17 0000-00-00 No No Current