FDA.reportPublic FDA data

Cyclobenzaprine hydrochloride

Product NDC
29300-413
11-digit product format
293000413
Labeler code
29300
Product ID
29300-413_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
5 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 HYDROCHLORIDE5 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
29300-413-01Cyclobenzaprine hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
29300-413-05Cyclobenzaprine hydrochloride500 in 1 BOTTLETABLET, FILM COATED5005
29300-413-10Cyclobenzaprine hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10005
29300-413-19Cyclobenzaprine hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-413-01EA - Each29300-413ceb23fc7-aac7-46aa-a985-77035f57735812021-03-02
29300-413-05EA - Each29300-41363166e88-fab7-498e-8603-f5e1a4cd869c12021-03-02
29300-413-19EA - Each29300-4137b280a3b-17b5-4c07-9921-b498dfa4021412022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-413CYCLOBENZAPRINE 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
828320cyclobenzaprine HCl 5 MG Oral TabletPSN6ebaccfc-f57c-4547-ade0-6a6e204f5ea0102
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD6ebaccfc-f57c-4547-ade0-6a6e204f5ea0102
828320cyclobenzaprine HCl 5 MG Oral TabletPSNeb2b24b1-2851-440f-9075-b6a123a1fd5c13
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDeb2b24b1-2851-440f-9075-b6a123a1fd5c13
828320cyclobenzaprine HCl 5 MG Oral TabletPSNf2286776-a7de-42dc-b745-d250e741eeb611
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDf2286776-a7de-42dc-b745-d250e741eeb611
828320cyclobenzaprine HCl 5 MG Oral TabletPSNc859f63a-09de-4eec-e053-2a95a90a312f9
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDc859f63a-09de-4eec-e053-2a95a90a312f9
828320cyclobenzaprine HCl 5 MG Oral TabletPSNcdc5b438-6b6b-0cdd-e053-2a95a90a7f757
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDcdc5b438-6b6b-0cdd-e053-2a95a90a7f757
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
828320cyclobenzaprine HCl 5 MG Oral TabletPSNac8ae965-af50-41d3-8df5-ca6daf4bbd1c3
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDac8ae965-af50-41d3-8df5-ca6daf4bbd1c3
828348cyclobenzaprine HCl 10 MG Oral TabletPSN820dca15-5b7f-41e0-955f-73f9427092642
828320cyclobenzaprine HCl 5 MG Oral TabletPSN820dca15-5b7f-41e0-955f-73f9427092642
828320cyclobenzaprine HCl 5 MG Oral TabletPSN106d9730-5938-8f27-e063-6294a90adc682
828299cyclobenzaprine HCl 7.5 MG Oral TabletPSN820dca15-5b7f-41e0-955f-73f9427092642
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD820dca15-5b7f-41e0-955f-73f9427092642
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD106d9730-5938-8f27-e063-6294a90adc682
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD820dca15-5b7f-41e0-955f-73f9427092642
828299cyclobenzaprine hydrochloride 7.5 MG Oral TabletSCD820dca15-5b7f-41e0-955f-73f9427092642
828320cyclobenzaprine HCl 5 MG Oral TabletPSNe332763b-00c6-41bf-84ae-a07d9ef796971
828320cyclobenzaprine HCl 5 MG Oral TabletPSNeb94a3f6-24dd-4847-8c05-22c49b8536551
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDe332763b-00c6-41bf-84ae-a07d9ef796971
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCDeb94a3f6-24dd-4847-8c05-22c49b8536551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-413-0129300041301100 TABLET, FILM COATED in 1 BOTTLE (29300-413-01) 2020-09-300000-00-00NoNoCurrent
29300-413-0529300041305500 TABLET, FILM COATED in 1 BOTTLE (29300-413-05) 2020-09-300000-00-00NoNoCurrent
29300-413-10293000413101000 TABLET, FILM COATED in 1 BOTTLE (29300-413-10) 2020-09-300000-00-00NoNoCurrent
29300-413-192930004131990 TABLET, FILM COATED in 1 BOTTLE (29300-413-19) 2021-11-180000-00-00NoNoCurrent