Home NDC 12634-909 Promethazine Hydrochloride and Codeine Phosphate
Product NDC 12634-909
11-digit product format 126340909
Labeler code 12634
Product ID 12634-909_49d71d3b-fb89-5738-e054-00144ff8d46c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride and Codeine Phosphate
Dosage form SYRUP
Route ORAL
Labeler Apotheca Inc
Application ANDA040151
Marketing category ANDA
Marketing start 1997-08-26
Marketing end 0000-00-00
Substance CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Active strength 10 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 2019-12-31
Current FDA listing Historical FDA.report record 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 A040151-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP / ORAL 1997-08-26
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.
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 2026-08-01 22:54:32 2026-06 A040151-001 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE 10MG/5ML;6.25MG/5ML SYRUP / ORAL 1997-08-26 a50c72e98297…
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 12634-909-02 Promethazine Hydrochloride and Codeine Phosphate 60 mL in 1 BOTTLE SYRUP 60 5 12634-909-04 Promethazine Hydrochloride and Codeine Phosphate 120 mL in 1 BOTTLE SYRUP 120 5 12634-909-06 Promethazine Hydrochloride and Codeine Phosphate 178 mL in 1 BOTTLE SYRUP 178 5 12634-909-08 Promethazine Hydrochloride and Codeine Phosphate 237 mL in 1 BOTTLE SYRUP 237 5 12634-909-16 Promethazine Hydrochloride and Codeine Phosphate 473 mL in 1 BOTTLE SYRUP 473 5 12634-909-28 Promethazine Hydrochloride and Codeine Phosphate 3785 mL in 1 BOTTLE SYRUP 3785 5 12634-909-32 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 WITH CODEINE LIQUID [APOTHECA, INC.] 1 PROMETHAZINE HYDROCHLORIDE ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 CODEINE ACTIVE MOIETY Q830PW7520 PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 PROMETHAZINE ACTIVE MOIETY FF28EJQ494 PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 CITRIC ACID INACTIVE INGREDIENT 2968PHW8QP PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 SODIUM PROPIONATE INACTIVE INGREDIENT DK6Y9P42IN PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-909 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA INC] 5 Legacy NDC, 7 package rows 20170327_47d4eb4f-6dd4-44b9-aea1-19c4bfc1d425.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 12634-909-02 12634090902 60 mL in 1 BOTTLE 60 ml Historical 12634-909-04 12634090904 120 mL in 1 BOTTLE 120 ml Historical 12634-909-06 12634090906 178 mL in 1 BOTTLE 178 ml Historical 12634-909-08 12634090908 237 mL in 1 BOTTLE 237 ml Historical 12634-909-16 12634090916 473 mL in 1 BOTTLE 473 ml Historical 12634-909-28 12634090928 3785 mL in 1 BOTTLE 3785 ml Historical 12634-909-32 12634090932 946 mL in 1 BOTTLE 946 ml Historical