promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

promethazine hydrochloride 6.25 mg/5mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-774
Product ID 68999-774_441fd999-03ba-ed67-e063-6294a90ae229
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040026
Listing Expiration 2026-12-31
Marketing Start 1998-09-25

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68999774
Hyphenated Format 68999-774

Supplemental Identifiers

RxCUI
992432
UNII
R61ZEH7I1I

Packaging Origin

Original Packager
true

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 ANDA040026 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-774-10)
  • 2 TRAY in 1 BOX (68999-774-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-774-05)
source: ndc

Packages (2)

68999-774-23 2 TRAY in 1 BOX (68999-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-774-10) 68999-774-24 2 TRAY in 1 BOX (68999-774-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-774-05)

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": "441fd999-03ba-ed67-e063-6294a90ae229", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["e5d2156d-1f66-4fdf-a3ae-5e1325218c8b"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-774-23)  / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-774-10)", "package_ndc": "68999-774-23", "marketing_start_date": "20251120"}, {"sample": false, "description": "2 TRAY in 1 BOX (68999-774-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-774-05)", "package_ndc": "68999-774-24", "marketing_start_date": "20251120"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "68999-774_441fd999-03ba-ed67-e063-6294a90ae229", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "68999-774", "generic_name": "PROMETHAZINE HYDROCHLORIDE", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROMETHAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040026", "marketing_category": "ANDA", "marketing_start_date": "19980925", "listing_expiration_date": "20261231"}