promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: atlantic biologicals corp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler atlantic biologicals corp
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

promethazine hydrochloride 6.25 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP

Identifiers & Regulatory

Product NDC 17856-0059
Product ID 17856-0059_45b43457-b9cd-09a2-e063-6294a90a698d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091675
Listing Expiration 2026-12-31
Marketing Start 2012-06-08

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178560059
Hyphenated Format 17856-0059

Supplemental Identifiers

RxCUI
992432
UNII
R61ZEH7I1I

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name promethazine hydrochloride (source: ndc)
Generic Name promethazine hydrochloride (source: ndc)
Application Number ANDA091675 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
source: ndc
Packaging
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0059-1) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

17856-0059-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0059-1) / 5 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

promethazine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45b43457-b9cd-09a2-e063-6294a90a698d", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["69934bbb-922c-4752-b253-f2f07340de8d"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP"]}, "finished": true, "packaging": [{"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0059-1)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "17856-0059-1", "marketing_start_date": "20231113"}], "brand_name": "promethazine hydrochloride", "product_id": "17856-0059_45b43457-b9cd-09a2-e063-6294a90a698d", "dosage_form": "SYRUP", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "17856-0059", "generic_name": "promethazine hydrochloride", "labeler_name": "ATLANTIC BIOLOGICALS CORP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "promethazine hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA091675", "marketing_category": "ANDA", "marketing_start_date": "20120608", "listing_expiration_date": "20261231"}