Home NDC 12634-907-06 promethazine hydrochloride and codeine phosphate
Product NDC 12634-907
Requested package NDC 12634-907-06
11-digit product format 126340907
Labeler code 12634
Product ID 12634-907_477cedee-6bcf-2a34-e054-00144ff8d46c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name promethazine hydrochloride and codeine phosphate
Dosage form SYRUP
Route ORAL
Labeler Apotheca Inc.
Application ANDA090180
Marketing category ANDA
Marketing start 2010-03-17
Marketing end 0000-00-00
Substance PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
Active strength 6 mg/5mL; mg/5mL
Pharmacologic classes Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CV
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…
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 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090180-001 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 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090180-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL AA 2010-03-17 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 12634-907-02 promethazine hydrochloride and codeine phosphate 60 mL in 1 BOTTLE SYRUP 60 5 12634-907-04 promethazine hydrochloride and codeine phosphate 120 mL in 1 BOTTLE SYRUP 120 5 12634-907-06 promethazine hydrochloride and codeine phosphate 178 mL in 1 BOTTLE SYRUP 178 5 12634-907-08 promethazine hydrochloride and codeine phosphate 237 mL in 1 BOTTLE SYRUP 237 5 12634-907-16 promethazine hydrochloride and codeine phosphate 473 mL in 1 BOTTLE SYRUP 473 5 12634-907-28 promethazine hydrochloride and codeine phosphate 3785 mL in 1 BLISTER PACK SYRUP 3785 5 12634-907-32 promethazine hydrochloride and codeine phosphate 946 mL in 1 BOTTLE SYRUP 946 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 PROMETHAZINE HYDROCHLORIDE ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 PROMETHAZINE ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-907 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA INC.] 5 Legacy NDC, 7 package rows 20170201_68639fd1-3fd5-4459-8018-51f136e3ed37.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 12634-907-06 12634090706 178 mL in 1 BOTTLE (12634-907-06) 178 ml 2010-03-17 0000-00-00 No No Current