Home NDC 72189-280-60 CYCLOBENZAPRINE HYDROCHLORIDE
Product NDC 72189-280
Requested package NDC 72189-280-60
11-digit product format 721890280
Labeler code 72189
Product ID 72189-280_4c5cd6ce-a63a-c9fd-e063-6394a90ab906
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CYCLOBENZAPRINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DirectRx
Application ANDA213324
Marketing category ANDA
Marketing start 2021-10-07
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 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05
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.
Product history page 1 of 3 · 120 observed 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 2026-10-15 13:18:30 2026-09 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213324-002 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2020-07-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213324-003 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213324-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-07-06 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base CYCLOBENZAPRINE HYDROCHLORIDE
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 828320 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72189-280-15 CYCLOBENZAPRINE HYDROCHLORIDE 15 in 1 BOTTLE TABLET, FILM COATED 15 7 72189-280-20 CYCLOBENZAPRINE HYDROCHLORIDE 20 in 1 BOTTLE TABLET, FILM COATED 20 7 72189-280-30 CYCLOBENZAPRINE HYDROCHLORIDE 30 in 1 BOTTLE TABLET, FILM COATED 30 7 72189-280-60 CYCLOBENZAPRINE HYDROCHLORIDE 60 in 1 BOTTLE TABLET, FILM COATED 60 7 72189-280-82 CYCLOBENZAPRINE HYDROCHLORIDE 180 in 1 BOTTLE TABLET, FILM COATED 180 7 72189-280-90 CYCLOBENZAPRINE HYDROCHLORIDE 90 in 1 BOTTLE TABLET, FILM COATED 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-280 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DIRECTRX] 5 Current NDC, Legacy NDC, 6 package rows 20231212_cdc5b438-6b6b-0cdd-e053-2a95a90a7f75.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 2 of 2 · 24 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72189-280-60 72189028060 60 TABLET, FILM COATED in 1 BOTTLE (72189-280-60) 2021-10-07 0000-00-00 No No Current