cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: sola pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler sola pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
SOLA Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70512-872
Product ID 70512-872_3b2ac0d1-9247-b044-e063-6294a90a6780
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077563
Listing Expiration 2026-12-31
Marketing Start 2025-07-31

Pharmacologic Class

Classes
centrally-mediated muscle relaxation [pe] muscle relaxant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70512872
Hyphenated Format 70512-872

Supplemental Identifiers

RxCUI
828348
UNII
0VE05JYS2P

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 cyclobenzaprine hydrochloride (source: ndc)
Generic Name cyclobenzaprine hydrochloride (source: ndc)
Application Number ANDA077563 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (70512-872-10)
source: ndc

Packages (1)

70512-872-10 100 TABLET, FILM COATED in 1 BOTTLE (70512-872-10)

Ingredients (1)

cyclobenzaprine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cyclobenzaprine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b2ac0d1-9247-b044-e063-6294a90a6780", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["db930d05-3f92-41f1-888c-301b2c4565e6"], "manufacturer_name": ["SOLA Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70512-872-10)", "package_ndc": "70512-872-10", "marketing_start_date": "20250731"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "70512-872_3b2ac0d1-9247-b044-e063-6294a90a6780", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "70512-872", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "SOLA Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077563", "marketing_category": "ANDA", "marketing_start_date": "20250731", "listing_expiration_date": "20261231"}