Home NDC 72888-038 Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Product NDC 72888-038
11-digit product format 728880038
Labeler code 72888
Product ID 72888-038_55262a03-3832-160b-e063-6294a90af0d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form SOLUTION
Route ORAL
Labeler Advagen Pharma Ltd
Application ANDA220869
Marketing category ANDA
Marketing start 2026-06-23
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
Listing certified through 2027-12-31
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 A220869-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2026-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220869-001 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.
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 A220869-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2026-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220869-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2026-06-23 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220869-001 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2026-06-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220869-001 AA 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220869-001 AA 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220869-001 AA 1 a50c72e98297…
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
Listing expiration 2027-12-31 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72888-038-01 72888003801 473 mL in 1 BOTTLE (72888-038-01) 473 ml 2026-06-23 No No Current 72888-038-02 72888003802 118 mL in 1 BOTTLE (72888-038-02) 118 ml 2026-06-23 No No Current