Home NDC 68071-3551 Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
Product NDC 68071-3551
11-digit product format 680713551
Labeler code 68071
Product ID 68071-3551_2d3fb2d4-6352-3f26-e063-6294a90a0163
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
Dosage form SOLUTION
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA040649
Marketing category ANDA
Marketing start 2020-10-05
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 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-3551-4 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-3551-4 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-3551-4 0efc9e666f02…f202fb6c5f17…
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 A040649-001 PROMETHAZINE DM DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040649-001 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 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2006-02-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2006-02-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2006-02-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL 2006-02-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 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 Oral Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup R61ZEH7I1I 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-3551-4 Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution 118 mL in 1 BOTTLE SOLUTION 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3551 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION SOLUTION [NUCARE PHARMACEUTICALS,INC.] 2 Current NDC, 1 package rows 20250205_0b7bfbab-decb-970c-e063-6394a90a50ef.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION ATLANTIC BIOLOGICALS CORP. 3983d6d3-8bf4-4a88-962f-9bf72fd6e685 2026-07-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040649 application number: ANDA040649 Promethazine DM PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE PAI Holdings, LLC dba PAI Pharma 1d47280d-28c9-4701-8c5f-a6e6b524083b 2025-05-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040649 application number: ANDA040649 Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION NuCare Pharmaceuticals,Inc. 0b7bfbab-decb-970c-e063-6394a90a50ef 2025-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040649 application number: ANDA040649 ndc (product): 68071-3551 Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL A-S Medication Solutions 9c3e0e87-b2f5-4a09-9db8-6d088d2a5f25 2023-08-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040649 application number: ANDA040649 Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION Proficient Rx LP 68a4c521-6db0-4e94-9906-96e96e251301 2022-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040649 application number: ANDA040649
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68071-3551-4 68071355104 118 mL in 1 BOTTLE (68071-3551-4) 118 ml 2023-12-01 No No Current