FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
29300-415
11-digit product format
293000415
Labeler code
29300
Product ID
29300-415_cc113cd6-8904-4485-b1b2-15dd5ff7468b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA213324
Marketing category
ANDA
Marketing start
2020-07-06
Substance
CYCLOBENZAPRINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyclobenzaprine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOBENZAPRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0VE05JYS2P
Rxcui828299, 828320, 828348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-415-01Cyclobenzaprine hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
29300-415-05Cyclobenzaprine hydrochloride500 in 1 BOTTLETABLET, FILM COATED5005
29300-415-10Cyclobenzaprine hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10005
29300-415-19Cyclobenzaprine hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-415-01EA - Each29300-4153eae8eaf-f0f0-4169-964c-211efb14f50612021-03-02
29300-415-10EA - Each29300-4157fccd14a-be90-4e2a-ae96-97136dfa20af12021-03-02
29300-415-19EA - Each29300-41518a04da0-84ee-45b1-bd5d-a0264521d24d12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-415CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5Current NDC, Legacy NDC, 4 package rows20230105_1adcdd8a-30f9-4a7b-853c-948a5589acab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4a2d3cae-5c64-4986-9707-cc213b70b7ad103
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4a2d3cae-5c64-4986-9707-cc213b70b7ad103
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf3187074-6b55-44a3-b969-40a808eb034a13
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf3187074-6b55-44a3-b969-40a808eb034a13
828348cyclobenzaprine HCl 10 MG Oral TabletPSN51d85ea8-8317-4a76-a108-20383f118ad49
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD51d85ea8-8317-4a76-a108-20383f118ad49
828348cyclobenzaprine HCl 10 MG Oral TabletPSN6b06b11c-0546-4f6e-9509-ba612bbcb9fd8
828348cyclobenzaprine HCl 10 MG Oral TabletPSNbf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba8
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDbf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba8
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD6b06b11c-0546-4f6e-9509-ba612bbcb9fd8
828348cyclobenzaprine HCl 10 MG Oral TabletPSN1cb40f47-7fbb-4537-922d-04a08dd921c56
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD1cb40f47-7fbb-4537-922d-04a08dd921c56
828348cyclobenzaprine HCl 10 MG Oral TabletPSN1adcdd8a-30f9-4a7b-853c-948a5589acab5
828320cyclobenzaprine HCl 5 MG Oral TabletPSN1adcdd8a-30f9-4a7b-853c-948a5589acab5
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN1adcdd8a-30f9-4a7b-853c-948a5589acab5
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD1adcdd8a-30f9-4a7b-853c-948a5589acab5
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD1adcdd8a-30f9-4a7b-853c-948a5589acab5
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD1adcdd8a-30f9-4a7b-853c-948a5589acab5
828348cyclobenzaprine HCl 10 MG Oral TabletPSN348c7ad4-b380-4b78-88f4-106b94079f523
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD348c7ad4-b380-4b78-88f4-106b94079f523
828348cyclobenzaprine HCl 10 MG Oral TabletPSNa17f0f83-e17c-4c71-b6a2-404cd0d82d662
828348cyclobenzaprine HCl 10 MG Oral TabletPSN09d0e2fc-76a4-bb7d-e063-6394a90a4a7d2
828348cyclobenzaprine HCl 10 MG Oral TabletPSNfbd38abb-02ae-1a36-e053-6294a90abe652
828348cyclobenzaprine HCl 10 MG Oral TabletPSN820dca15-5b7f-41e0-955f-73f9427092642
828320cyclobenzaprine HCl 5 MG Oral TabletPSN820dca15-5b7f-41e0-955f-73f9427092642
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN820dca15-5b7f-41e0-955f-73f9427092642
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD820dca15-5b7f-41e0-955f-73f9427092642
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDa17f0f83-e17c-4c71-b6a2-404cd0d82d662
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD09d0e2fc-76a4-bb7d-e063-6394a90a4a7d2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDfbd38abb-02ae-1a36-e053-6294a90abe652
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD820dca15-5b7f-41e0-955f-73f9427092642
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD820dca15-5b7f-41e0-955f-73f9427092642
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4383b26f-c39f-3d6a-e063-6294a90aba031
828348cyclobenzaprine HCl 10 MG Oral TabletPSNf3d20bc8-ca02-11f5-e053-2995a90a720a1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4383b26f-c39f-3d6a-e063-6294a90aba031
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDf3d20bc8-ca02-11f5-e053-2995a90a720a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-415-0129300041501100 TABLET, FILM COATED in 1 BOTTLE (29300-415-01) 2020-09-300000-00-00NoNoCurrent
29300-415-0529300041505500 TABLET, FILM COATED in 1 BOTTLE (29300-415-05) 2020-09-300000-00-00NoNoCurrent
29300-415-10293000415101000 TABLET, FILM COATED in 1 BOTTLE (29300-415-10) 2020-09-300000-00-00NoNoCurrent
29300-415-192930004151990 TABLET, FILM COATED in 1 BOTTLE (29300-415-19) 2021-11-180000-00-00NoNoCurrent