PROMETHAZINE HCL

Product NDC
64679-760
11-digit product format
646790760
Labeler code
64679
Product ID
64679-760_7555f67d-ea85-44e4-9ed4-9c84d7f76c69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Wockhardt USA LLC.
Application
ANDA040785
Marketing category
ANDA
Marketing start
2009-12-23
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/mL
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64679-760DDiscontinued by firm2026-08-03
excluded packagepackage64679-76064679-760-01DDiscontinued by firm2026-08-03
excluded packagepackage64679-76064679-760-02DDiscontinued by firm2026-08-03
excluded packagepackage64679-76064679-760-03DDiscontinued by firm2026-08-03
excluded packagepackage64679-76064679-760-04DDiscontinued by firm2026-08-03

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 2 · 90 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 packagepackage64679-760-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-760-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-760-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-760-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-760-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-760-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-760-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-760-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-760-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-760-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-760-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-760-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-760-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-760-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-760-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-760-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-760-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-760-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-760-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-760-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-760-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-760-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-760-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-760-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-760-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-760-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-760-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-760-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-760-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-760-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-760-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-760-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-760-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-760-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-760-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-760-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-760-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-760-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-760-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-760-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-760-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-760-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-760-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-760-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-760-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-760-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-760-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-760-02557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040785-001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-26
A040785-002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-26

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040785-001PROMETHAZINE HYDROCHLORIDE25MG/MLINJECTABLE / INJECTION2008-09-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A040785-002PROMETHAZINE HYDROCHLORIDE50MG/MLINJECTABLE / INJECTION2008-09-26782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-760PROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WOCKHARDT USA LLC.]3Legacy NDC20191128_cb06c97d-3b98-4c29-bcb2-5b04f41db481.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64679-760-016467907600125 VIAL, SINGLE-DOSE in 1 CARTON (64679-760-01) > 1 mL in 1 VIAL, SINGLE-DOSE2009-12-230000-00-00NoNoCurrent
64679-760-02646790760021 VIAL, SINGLE-DOSE in 1 CARTON (64679-760-02) > 1 mL in 1 VIAL, SINGLE-DOSE2009-12-230000-00-00NoNoCurrent
64679-760-03646790760035 VIAL, SINGLE-DOSE in 1 CARTON (64679-760-03) > 1 mL in 1 VIAL, SINGLE-DOSE2009-12-230000-00-00NoNoCurrent
64679-760-046467907600410 VIAL, SINGLE-DOSE in 1 CARTON (64679-760-04) > 1 mL in 1 VIAL, SINGLE-DOSE2009-12-230000-00-00NoNoCurrent