Home NDC 84549-525-03 PROMETHAZINE HYDROCHLORIDE
Product NDC 84549-525
Requested package NDC 84549-525-03
11-digit product format 845490525
Labeler code 84549
Product ID 84549-525_45b09a50-dab1-e83d-e063-6394a90aa813
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROMETHAZINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler ProPharma Distribution
Application ANDA040737
Marketing category ANDA
Marketing start 2015-01-30
Substance PROMETHAZINE HYDROCHLORIDE
Active strength 25 mg/mL
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 A040737-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 A040737-002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 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 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040737-001 PROMETHAZINE HYDROCHLORIDE 25MG/ML INJECTABLE / INJECTION AP 2008-04-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040737-002 PROMETHAZINE HYDROCHLORIDE 50MG/ML INJECTABLE / INJECTION AP 2008-04-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PROMETHAZINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROMETHAZINE HYDROCHLORIDE 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R61ZEH7I1I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992460 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 84549-525-03 PROMETHAZINE HYDROCHLORIDE 1 mL in 1 AMPULE INJECTION, SOLUTION 1 1
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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE ProPharma Distribution 45b09a50-dab2-e83d-e063-6394a90aa813 2025-12-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040737 application number: ANDA040737 ndc (package): 84549-525-03 ndc (product): 84549-525 ndc11 (package): 84549052503 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE XGen Pharmaceuticals DJB, Inc. b6f6698f-f23c-452a-9b38-bbb96ab88ae4 2024-01-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040737 application number: ANDA040737 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE XGen Pharmaceuticals DJB, Inc. 1d02d52b-84bb-4e81-b352-125029eb39f6 2024-01-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040737 application number: ANDA040737
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84549-525-03 84549052503 1 mL in 1 AMPULE (84549-525-03) 1 ml 2025-12-11 No No Current