Home NDC 50090-6467 Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Product NDC 50090-6467
11-digit product format 500906467
Labeler code 50090
Product ID 50090-6467_17cc096b-1c05-43c4-a4e7-68f633ca212a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name promethazine hydrochloride and dextromethorphan hydrobromide
Dosage form SYRUP
Route ORAL
Labeler A-S Medication Solutions
Application ANDA088864
Marketing category ANDA
Marketing start 1985-01-04
Substance DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active strength 15; 6.25 mg/5mL; mg/5mL
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 42 .
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 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088864-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088864-001 PROMETHAZINE W/ DEXTROMETHORPHAN 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 1985-01-04 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R61ZEH7I1I Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991528 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 50090-6467-0 Promethazine Hydrochloride and Dextromethorphan Hydrobromide 473 mL in 1 BOTTLE, PLASTIC SYRUP 473 2 50090-6467-1 Promethazine Hydrochloride and Dextromethorphan Hydrobromide 473 mL in 1 BOTTLE, PLASTIC SYRUP 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6467 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [A-S MEDICATION SOLUTIONS] 2 Current NDC, 2 package rows 20230712_ee227c52-2cd8-4a06-a2de-a257f1f4732a.zip
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-6467-0 50090646700 473 mL in 1 BOTTLE, PLASTIC (50090-6467-0) 473 ml 2023-05-08 No No Current 50090-6467-1 50090646701 473 mL in 1 BOTTLE, PLASTIC (50090-6467-1) 473 ml 2023-05-08 No No Current