Home NDC 0713-0823 Promethazine Hydrochloride and Codeine Phosphate
Product NDC 0713-0823
11-digit product format 007130823
Labeler code 0713
Product ID 0713-0823_ad6f539c-d968-4a3b-9550-ab7e78bee74c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride and Codeine Phosphate
Dosage form SOLUTION
Route ORAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA200386
Marketing category ANDA
Marketing start 2025-12-19
Substance CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Active strength 10; 6.25 mg/5mL; mg/5mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
DEA schedule CV
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 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200386-001 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 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA RS 2012-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Promethazine Hydrochloride and Codeine Phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL CODEINE PHOSPHATE 10 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 GSL05Y1MN6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991486 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 0713-0823-75 Promethazine Hydrochloride and Codeine Phosphate 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 Codeine Phosphate PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE Cosette Pharmaceuticals, Inc. 3b02cda4-9b24-79c9-e063-6294a90af5b9 2025-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200386 application number: ANDA200386 ndc (product): 0713-0823 Promethazine Hydrochloride and Codeine Phosphate PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE Cranbury Pharmaceuticals, LLC 785c605e-1907-4fac-8b69-d504a2076f8e 2025-12-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200386 application number: ANDA200386 Promethazine Hydrochloride and Codeine Phosphate PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE ATLANTIC BIOLOGICALS CORP. f8fb13e3-bc09-4004-a911-a38b6bbb0058 2025-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200386 application number: ANDA200386 Promethazine Hydrochloride and Codeine Phosphate PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE Bryant Ranch Prepack df2c24ba-1c88-4ec3-b2a1-801358ec645c 2024-04-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200386 application number: ANDA200386
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0713-0823-75 00713082375 473 mL in 1 BOTTLE, PLASTIC (0713-0823-75) 473 ml 2025-12-19 No No Current