Home NDC 27808-065 Promethazine Hydrochloride and Codeine Phosphate
Product NDC 27808-065
11-digit product format 278080065
Labeler code 27808
Product ID 27808-065_981526cb-82c9-4a44-a891-7c44c708163e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride and Codeine Phosphate
Dosage form SOLUTION
Route ORAL
Labeler Cranbury Pharmaceuticals, LLC
Application ANDA200386
Marketing category ANDA
Marketing start 2018-03-12
Marketing end 2027-03-01
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
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 27808-065 27808-065-01 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200386-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2012-06-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 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 ndc (product): 27808-065 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
Additional Listing Data#
Finished product Yes
Brand name base Promethazine Hydrochloride and Codeine Phosphate Active Ingredients# Ingredient, Strength table Ingredient Strength PROMETHAZINE HYDROCHLORIDE 10 mg/5mL CODEINE PHOSPHATE 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 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 27808-065-01 Promethazine Hydrochloride and Codeine Phosphate 237 mL in 1 BOTTLE, PLASTIC SOLUTION 237 13 27808-065-02 Promethazine Hydrochloride and Codeine Phosphate 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27808-065 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION [TRIS PHARMA INC] 10 Current NDC, Legacy NDC, 2 package rows 20231220_785c605e-1907-4fac-8b69-d504a2076f8e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27808-065-01 27808006501 237 mL in 1 BOTTLE, PLASTIC 237 ml Historical 27808-065-02 27808006502 473 mL in 1 BOTTLE, PLASTIC (27808-065-02) 473 ml 2018-03-12 2027-03-01 No No Current