Home NDC 64980-655 Cyclobenzaprine Hydrochloride
Product NDC 64980-655
11-digit product format 649800655
Labeler code 64980
Product ID 64980-655_0512aebe-5f3a-4d41-9a41-7c37e001af75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA218936
Marketing category ANDA
Marketing start 2025-02-19
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218936-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2024-09-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218936-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2024-09-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218936-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2024-09-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cyclobenzaprine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0VE05JYS2P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 828320 Internal RxNorm lookup 828348 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64980-655-01 Cyclobenzaprine Hydrochloride 100 in 1 BOTTLE TABLET 100 1 64980-655-10 Cyclobenzaprine Hydrochloride 1000 in 1 BOTTLE TABLET 1000 1 64980-655-50 Cyclobenzaprine Hydrochloride 500 in 1 BOTTLE TABLET 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-655 CYCLOBENZAPRINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 3 package rows 20250223_6018b6e9-938d-4fc9-86d7-1fd1d7bfcc58.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64980-655-01 64980065501 100 TABLET in 1 BOTTLE (64980-655-01) 100 tablet 2025-02-19 No No Current 64980-655-10 64980065510 1000 TABLET in 1 BOTTLE (64980-655-10) 1000 tablet 2025-02-19 No No Current 64980-655-50 64980065550 500 TABLET in 1 BOTTLE (64980-655-50) 500 tablet 2025-02-19 No No Current