Home NDC 64679-761 PROMETHAZINE HCL
Product NDC 64679-761
11-digit product format 646790761
Labeler code 64679
Product ID 64679-761_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 50 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 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.
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 A040785-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 A040785-002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26
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 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 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040785-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION 2008-09-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040785-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION 2008-09-26 782e0a99824c…
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64679-761-01 2025-12-25 Promethazine HCl Injection, USP Rx only 64679-761-02 2025-12-25 Promethazine HCl Injection, USP Rx only 64679-761-03 2025-12-25 Promethazine HCl Injection, USP Rx only 64679-761-04 2025-12-25 Promethazine HCl Injection, USP Rx only 64679-761-01 2022-01-28 Promethazine HCl Injection, USP Rx only 64679-761-02 2022-01-28 Promethazine HCl Injection, USP Rx only 64679-761-03 2022-01-28 Promethazine HCl Injection, USP Rx only 64679-761-04 2022-01-28 Promethazine HCl Injection, USP Rx only
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64679-761 PROMETHAZINE HCL (PROMETHAZINE HYDROCHLORIDE) INJECTION [WOCKHARDT USA LLC.] 3 Legacy NDC 20191128_cb06c97d-3b98-4c29-bcb2-5b04f41db481.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64679-761-01 64679076101 25 VIAL, SINGLE-DOSE in 1 CARTON (64679-761-01) > 1 mL in 1 VIAL, SINGLE-DOSE 2009-12-23 0000-00-00 No No Current 64679-761-02 64679076102 5 VIAL, SINGLE-DOSE in 1 CARTON (64679-761-02) > 1 mL in 1 VIAL, SINGLE-DOSE 2009-12-23 0000-00-00 No No Current 64679-761-03 64679076103 10 VIAL, SINGLE-DOSE in 1 CARTON (64679-761-03) > 1 mL in 1 VIAL, SINGLE-DOSE 2009-12-23 0000-00-00 No No Current 64679-761-04 64679076104 1 VIAL, SINGLE-DOSE in 1 CARTON (64679-761-04) > 1 mL in 1 VIAL, SINGLE-DOSE 2009-12-23 0000-00-00 No No Current