Home NDC 67544-251-30 Cyclobenzaprine Hydrochloride
Product NDC 67544-251
Requested package NDC 67544-251-30
11-digit product format 675440251
Labeler code 67544
Product ID 67544-251_41c6e9d2-bc3f-492e-b855-0acc742ebdeb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA071611
Marketing category ANDA
Marketing start 1989-05-03
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03
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 4 · 129 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 2026-09-14 22:38:34 2026-08 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071611-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071611-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2006-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071611-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1989-05-03 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 67544-251-15 Cyclobenzaprine Hydrochloride 15 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 15 2 67544-251-30 Cyclobenzaprine Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 67544-251-45 Cyclobenzaprine Hydrochloride 45 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 45 2 67544-251-53 Cyclobenzaprine Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 2 67544-251-60 Cyclobenzaprine Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2 67544-251-70 Cyclobenzaprine Hydrochloride 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 2 67544-251-80 Cyclobenzaprine Hydrochloride 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 2 67544-251-92 Cyclobenzaprine Hydrochloride 270 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 270 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CYCLOBENZAPRINE HYDROCHLORIDE ACTIVE INGREDIENT 0VE05JYS2P CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CYCLOBENZAPRINE ACTIVE MOIETY 69O5WQQ5TI CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-251 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 8 package rows 20191227_1d325ea3-fd3f-4cf7-9d07-d5144e7945f5.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 · 3 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 67544-251-30 67544025130 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-251-30) 2007-01-10 0000-00-00 No No Current