Home NDC 50383-804 Promethazine Hydrochloride and Codeine Phosphate
Product NDC 50383-804
11-digit product format 503830804
Labeler code 50383
Product ID 50383-804_6994efab-2353-4868-bcde-c3ee3a2b1e8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Promethazine Hydrochloride and Codeine Phosphate
Dosage form SOLUTION
Route ORAL
Labeler Akorn
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 2024-12-31
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 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 [HI-TECH PHARMACAL CO., INC.] 12 PROMETHAZINE HYDROCHLORIDE ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 PROMETHAZINE ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [HI-TECH PHARMACAL CO., INC.] 12 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 PROMETHAZINE HYDROCHLORIDE ACTIVE INGREDIENT R61ZEH7I1I PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 PROMETHAZINE ACTIVE MOIETY FF28EJQ494 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 SODIUM PROPIONATE INACTIVE INGREDIENT DK6Y9P42IN PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS] 2 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 50383-804 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION [AKORN] 28 Legacy NDC 20230112_168951c0-773d-4f3d-9745-cc6de2063b61.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 50383-804-04 50383080404 118 mL in 1 BOTTLE (50383-804-04) 118 ml 1997-08-26 0000-00-00 No No Current 50383-804-16 50383080416 473 mL in 1 BOTTLE (50383-804-16) 473 ml 1997-08-26 0000-00-00 No No Current