Home NDC 0603-1584-54 Promethazine Hydrochloride
Product NDC 0603-1584
Requested package NDC 0603-1584-54
11-digit product format 006031584
Labeler code 0603
Product ID 0603-1584_896908f5-e0f2-4ed0-8546-b24a0daef5aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Par Pharmaceutical
Application ANDA040643
Marketing category ANDA
Marketing start 2006-04-26
Marketing end 2021-05-31
Substance PROMETHAZINE HYDROCHLORIDE
Active strength 6 mg/5mL
Pharmacologic classes Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040643-001 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040643-001 AA
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 · 43 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 2026-09-14 22:38:34 2026-08 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL 2006-04-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040643-001 PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML SYRUP / ORAL AA 2006-04-26 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROMETHAZINE HYDROCHLORIDE ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 PROMETHAZINE ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE HYDROCHLORIDE SYRUP [QUALITEST PHARMACEUTICALS] 4 PROMETHAZINE HYDROCHLORIDE ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 PROMETHAZINE ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 CITRIC ACID INACTIVE INGREDIENT 2968PHW8QP PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE HYDROCHLORIDE SYRUP [DISPENSING SOLUTIONS, INC.] 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 · 1 matching rows.
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 0603-1584-54 00603158454 118 mL in 1 BOTTLE (0603-1584-54) 118 ml 2006-04-26 2021-04-30 No No Current