Home NDC 0121-1070 Promethazine DM
Product NDC 0121-1070
11-digit product format 001211070
Labeler code 0121
Product ID 0121-1070_acf1463f-bbbe-42e9-9b06-a306e95a4325
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA040649
Marketing category ANDA
Marketing start 2025-06-04
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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A040649-001 PROMETHAZINE DM 15MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2006-02-14 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Promethazine DM
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-1070-04 Promethazine DM 118 mL in 1 BOTTLE SOLUTION 118 1 0121-1070-16 Promethazine DM 473 mL in 1 BOTTLE 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 · 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 ndc (product): 0121-1070 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 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 0121-1070-04 00121107004 118 mL in 1 BOTTLE (0121-1070-04) 118 ml 2025-06-04 No No Current 0121-1070-16 00121107016 473 mL in 1 BOTTLE (0121-1070-16) 473 ml 2025-06-04 No No Current