Phenylephrine hydrochloride

Product NDC
16729-466
11-digit product format
167290466
Labeler code
16729
Product ID
16729-466_d9f34811-0e56-206b-e053-2a95a90af8a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA213237
Marketing category
ANDA
Marketing start
2022-03-11
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16729-466DDiscontinued by firm2026-08-17
excluded packagepackage16729-46616729-466-03DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16729-466-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16729-466-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16729-466-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16729-466-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16729-466-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16729-466-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16729-466-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16729-466-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16729-466-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16729-466-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16729-466-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16729-466-03557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213237-001PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01
A213237-002PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01
A213237-003PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01

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 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213237-002PHENYLEPHRINE HYDROCHLORIDE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213237-003PHENYLEPHRINE HYDROCHLORIDE100MG/10ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213237-001PHENYLEPHRINE HYDROCHLORIDE10MG/ML (10MG/ML)SOLUTION / INTRAVENOUS2020-07-011e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A213237-001AP118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213237-002AP118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213237-003AP118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213237-001AP115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213237-002AP115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213237-003AP115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213237-001AP115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213237-002AP115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213237-003AP115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213237-001AP114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213237-002AP114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213237-003AP114b0b4de00fa7…
2020-12-22 03:56 UTC2020-12A213237-001AP118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A213237-002AP118869cabd3fbd…
2020-12-22 03:56 UTC2020-12A213237-003AP118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213237-001AP11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A213237-002AP11c0c555d07b60…
2020-11-12 02:37 UTC2020-11A213237-003AP11c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213237-001AP116a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213237-002AP116a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213237-003AP116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213237-001AP111c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213237-002AP111c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213237-003AP111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213237-001AP11ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213237-002AP11ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213237-003AP11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213237-001AP11a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213237-002AP11a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213237-003AP11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213237-001AP119b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213237-002AP119b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213237-003AP119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213237-001AP11a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213237-002AP11a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213237-003AP11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213237-001AP113f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213237-002AP113f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213237-003AP113f0d92c62455…
2023-05-13 08:27 UTC2023-05A213237-001AP11053a50430f4f…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-466-03ML - Milliliter16729-466b6930bb7-6860-4608-a34c-9e0754eb3e3d12022-04-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-466-03167290466031 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16729-466-03) > 10 mL in 1 VIAL, PHARMACY BULK PACKAGE2022-03-110000-00-00NoNoCurrent