Home NDC 11788-094 CYCLOBENZAPRINE HYDROCHLORIDE
Product NDC 11788-094
11-digit product format 117880094
Labeler code 11788
Product ID 11788-094_ec39e6ed-4084-444e-8e30-73d135957876
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AiPing Pharmaceutical, Inc.
Application ANDA072854
Marketing category ANDA
Marketing start 2026-10-23
Substance CYCLOBENZAPRINE HYDROCHLORIDE
Active strength 7.5 mg/1
Pharmacologic classes Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag No
Current FDA listing Yes 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 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1991-11-19 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 A072854-003 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2026-05-13
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 · 92 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 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1991-11-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2006-02-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 A072854-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2026-05-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072854-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2026-05-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072854-003 CYCLOBENZAPRINE HYDROCHLORIDE 7.5MG TABLET / ORAL AB 2026-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072854-002 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL 2006-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072854-001 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL 1991-11-19 5d02ea3f76ae…
Observed Orange Book normalized TE history# 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 Active Ingredients# Ingredient, Strength table Ingredient Strength CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 11788-094-01 11788009401 100 TABLET, FILM COATED in 1 BOTTLE (11788-094-01) 2026-10-23 No No Current