FDA.reportPublic FDA data

Promethazine Hydrochloride and Codeine Phosphate

Product NDC
17856-0804
11-digit product format
178560804
Labeler code
17856
Product ID
17856-0804_bac94880-a702-43e3-ba7e-0c62928a0c31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Codeine Phosphate
Dosage form
SYRUP
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA040151
Marketing category
ANDA
Marketing start
1997-08-26
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0804IInactivated by FDA2026-07-31
excluded packagepackage17856-080417856-0804-5IInactivated by FDA2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040151-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE10MG/5ML;6.25MG/5MLSYRUP / ORAL1997-08-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040151-001PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE10MG/5ML;6.25MG/5MLSYRUP / ORAL1997-08-26a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0804-52020-01-31C16284748780-19d75b9d0-765d-f424-e053-dadaa90a57cePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0804-5ML - Milliliter17856-0804dc4a6c42-4bf5-4ae5-99b0-248c89f9643912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [ATLANTIC BIOLOGICALS CORPS]2