promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

promethazine hydrochloride 6.25 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-774
Product ID 62135-774_499ebc74-646b-4e6d-e063-6394a90ab998
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040026
Listing Expiration 2027-12-31
Marketing Start 1998-09-25

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135774
Hyphenated Format 62135-774

Supplemental Identifiers

RxCUI
992432
UPC
0362135774417 0362135774479
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 (62135-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-774-10)
  • 2 TRAY in 1 BOX (62135-774-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-774-05)
  • 120 mL in 1 BOTTLE (62135-774-41)
  • 473 mL in 1 BOTTLE (62135-774-47)
source: ndc

Packages (4)

62135-774-23 2 TRAY in 1 BOX (62135-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-774-10) 62135-774-24 2 TRAY in 1 BOX (62135-774-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-774-05) 62135-774-41 120 mL in 1 BOTTLE (62135-774-41) 62135-774-47 473 mL in 1 BOTTLE (62135-774-47)

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": "499ebc74-646b-4e6d-e063-6394a90ab998", "openfda": {"upc": ["0362135774417", "0362135774479"], "unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["2ca17cd4-460e-4d54-8c53-a58a2b80e5cb"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-774-23)  / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-774-10)", "package_ndc": "62135-774-23", "marketing_start_date": "20250210"}, {"sample": false, "description": "2 TRAY in 1 BOX (62135-774-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-774-05)", "package_ndc": "62135-774-24", "marketing_start_date": "20250210"}, {"sample": false, "description": "120 mL in 1 BOTTLE (62135-774-41)", "package_ndc": "62135-774-41", "marketing_start_date": "20231127"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62135-774-47)", "package_ndc": "62135-774-47", "marketing_start_date": "20231127"}], "brand_name": "PROMETHAZINE HYDROCHLORIDE", "product_id": "62135-774_499ebc74-646b-4e6d-e063-6394a90ab998", "dosage_form": "SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "62135-774", "generic_name": "PROMETHAZINE HYDROCHLORIDE", "labeler_name": "Chartwell 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": "20271231"}