carisoprodol tablets, usp, 350 mg

Generic: carisoprodol

Labeler: granulation technology, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carisoprodol tablets, usp, 350 mg
Generic Name carisoprodol
Labeler granulation technology, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carisoprodol 350 mg/1

Manufacturer
Granulation Technology, Inc.

Identifiers & Regulatory

Product NDC 63561-0127
Product ID 63561-0127_37394c09-4ae3-400c-e063-6294a90a65d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211789
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2025-06-11

Pharmacologic Class

Established (EPC)
muscle relaxant [epc]
Physiologic Effect
centrally-mediated muscle relaxation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 635610127
Hyphenated Format 63561-0127

Supplemental Identifiers

RxCUI
197446
UPC
0363561012722
UNII
21925K482H
NUI
N0000175730 N0000175737

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 carisoprodol tablets, usp, 350 mg (source: ndc)
Generic Name carisoprodol (source: ndc)
Application Number ANDA211789 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 350 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (63561-0127-1)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (63561-0127-2)
source: ndc

Packages (2)

63561-0127-1 100 TABLET in 1 BOTTLE, PLASTIC (63561-0127-1) 63561-0127-2 1000 TABLET in 1 BOTTLE, PLASTIC (63561-0127-2)

Ingredients (1)

carisoprodol (350 mg/1)

Linked Drug Pages (1)

Carisoprodol Tablets, USP, 350 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37394c09-4ae3-400c-e063-6294a90a65d2", "openfda": {"nui": ["N0000175730", "N0000175737"], "upc": ["0363561012722"], "unii": ["21925K482H"], "rxcui": ["197446"], "spl_set_id": ["2abd11e4-8ce4-4aeb-87c4-3af94c197714"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Granulation Technology, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (63561-0127-1)", "package_ndc": "63561-0127-1", "marketing_start_date": "20250611"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (63561-0127-2)", "package_ndc": "63561-0127-2", "marketing_start_date": "20250611"}], "brand_name": "Carisoprodol Tablets, USP, 350 mg", "product_id": "63561-0127_37394c09-4ae3-400c-e063-6294a90a65d2", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "63561-0127", "dea_schedule": "CIV", "generic_name": "Carisoprodol", "labeler_name": "Granulation Technology, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carisoprodol Tablets, USP, 350 mg", "active_ingredients": [{"name": "CARISOPRODOL", "strength": "350 mg/1"}], "application_number": "ANDA211789", "marketing_category": "ANDA", "marketing_start_date": "20250611", "listing_expiration_date": "20261231"}