Home NDC 43598-172 Biorphen
Product NDC 43598-172
11-digit product format 435980172
Labeler code 43598
Product ID 43598-172_884b0378-92e0-f3ed-176b-ff409f29747f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenylephrine hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Dr. Reddy's Laboratories Inc.
Application NDA212909
Marketing category NDA
Marketing start 2022-11-25
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength .1 mg/mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212909-001 BIORPHEN PHENYLEPHRINE HYDROCHLORIDE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 N212909-002 BIORPHEN PHENYLEPHRINE HYDROCHLORIDE 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N212909-001 AP
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 · 73 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 2026-02-19 14:30 UTC 2026-02 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212909-001 BIORPHEN 0.1MG/ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N212909-002 BIORPHEN 10MG/ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2021-03-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212909-001 BIORPHEN 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-10-21 87673890dc5c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Biorphen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE .1 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1666372 Internal RxNorm lookup 2262018 Internal RxNorm lookup 2533434 Internal RxNorm lookup 2533437 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43598-172-05 Biorphen 5 mL in 1 AMPULE INJECTION, SOLUTION 5 5 43598-172-15 Biorphen 10 in 1 CARTON INJECTION, SOLUTION 10 5 43598-172-25 Biorphen 5 mL in 1 VIAL INJECTION, SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-172 BIORPHEN (PHENYLEPHRINE HYDROCHLORIDE) INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC.] 3 Current NDC, Legacy NDC, 3 package rows 20240502_2f715e4e-b269-b935-d2c9-003cb29770be.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Biorphen PHENYLEPHRINE HYDROCHLORIDE Dr. Reddy's Laboratories Inc. 2f715e4e-b269-b935-d2c9-003cb29770be 2026-03-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 212909 application number: NDA212909 ndc (product): 43598-172
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 43598-172-05 43598017205 5 mL in 1 AMPULE 5 ml Historical 43598-172-15 43598017215 10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05) 10 ampule 2022-11-25 0000-00-00 No No Current 43598-172-25 43598017225 5 mL in 1 VIAL (43598-172-25) 5 ml 2024-05-10 No No Current