Home NDC 0713-0780 Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Product NDC 0713-0780
11-digit product format 007130780
Labeler code 0713
Product ID 0713-0780_3f7c7c58-c76e-b49c-e063-6294a90ace09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form SOLUTION
Route ORAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA091687
Marketing category ANDA
Marketing start 2025-09-19
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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A091687-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-28 e64feba35796…
Observed Orange Book normalized TE history# 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 0713-0780-75 Promethazine Hydrochloride and Dextromethorphan Hydrobromide 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 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 · 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 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 ndc (product): 0713-0780 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 Sample Exclude flag Status 0713-0780-75 00713078075 473 mL in 1 BOTTLE, PLASTIC (0713-0780-75) 473 ml 2025-09-19 No No Current