Home NDC 72162-2039 Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Product NDC 72162-2039
11-digit product format 721622039
Labeler code 72162
Product ID 72162-2039_4c93b759-804b-4e84-ba5d-37bb0895adf7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form SOLUTION
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091687
Marketing category ANDA
Marketing start 2014-01-31
Marketing end 2027-04-01
Substance PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 6.25; 15 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
Current FDA listing Yes 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 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091687-001 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 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2012-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2012-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2012-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2012-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2012-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2012-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2012-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2012-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Promethazine Hydrochloride and Dextromethorphan Hydrobromide 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 72162-2039-2 Promethazine Hydrochloride and Dextromethorphan Hydrobromide 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2039 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [BRYANT RANCH PREPACK] 102 Current NDC, 1 package rows 20241128_709519cb-d124-4469-b329-b67e1bba214b.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Promethazine Hydrochloride and Dextromethorphan Hydrobromide PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Bryant Ranch Prepack 709519cb-d124-4469-b329-b67e1bba214b 2026-03-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091687 application number: ANDA091687 ndc (product): 72162-2039 Promethazine Hydrochloride and Dextromethorphan Hydrobromide PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Cranbury Pharmaceuticals, LLC a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3 2025-12-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091687 application number: ANDA091687 Promethazine Hydrochloride and Dextromethorphan Hydrobromide PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Cosette Pharmaceuticals, Inc. e7b336d9-b1df-4a08-9b67-754346d365f4 2025-09-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091687 application number: ANDA091687 Promethazine Hydrochloride and Dextromethorphan Hydrobromide PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE A-S Medication Solutions e451cb8d-f856-479f-bee9-4cccab210b1e 2024-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091687 application number: ANDA091687
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 72162-2039-2 72162203902 473 mL in 1 BOTTLE, PLASTIC (72162-2039-2) 473 ml 2023-06-06 2027-04-01 No No Historical