Home NDC 71610-016 Cyclobenzaprine Hydrochloride
Product NDC 71610-016
11-digit product format 716100016
Labeler code 71610
Product ID 71610-016_a35560e7-0593-4c49-87b1-8971ff6df820
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA078048
Marketing category ANDA
Marketing start 2014-07-31
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 82 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 2026-02-19 14:30 UTC 2026-02 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078048-001 CYCLOBENZAPRINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-02-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078048-002 CYCLOBENZAPRINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-02-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 10 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 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 71610-016-30 Cyclobenzaprine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 3 71610-016-45 Cyclobenzaprine Hydrochloride 45 in 1 BOTTLE TABLET, FILM COATED 45 3 71610-016-53 Cyclobenzaprine Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 3 71610-016-70 Cyclobenzaprine Hydrochloride 120 in 1 BOTTLE TABLET, FILM COATED 120 3 71610-016-92 Cyclobenzaprine Hydrochloride 270 in 1 BOTTLE TABLET, FILM COATED 270 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-016 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Current NDC, Legacy NDC, 5 package rows 20200607_bb23383c-087a-4fb1-8917-edecd1ec4527.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE PD-Rx Pharmaceuticals, Inc. e505c31b-4618-4e4f-8da6-92030464004f 2025-10-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078048 application number: ANDA078048 Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE American Health Packaging 5f321a03-ccfb-4c11-ac60-a461a5580c69 2024-12-13 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078048 application number: ANDA078048 Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE Proficient Rx LP f14bc532-e30f-490f-b97b-d0dab9a2ba0c 2021-10-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078048 application number: ANDA078048 Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC bb23383c-087a-4fb1-8917-edecd1ec4527 2020-06-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078048 application number: ANDA078048 ndc (product): 71610-016 Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE KVK-TECH, Inc. 5b756c04-e7b8-4efe-815a-3f3e020727fb 2018-12-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078048 application number: ANDA078048
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 71610-016-30 71610001630 30 TABLET, FILM COATED in 1 BOTTLE (71610-016-30) 2020-04-08 0000-00-00 No No Current 71610-016-45 71610001645 45 TABLET, FILM COATED in 1 BOTTLE (71610-016-45) 2017-12-07 0000-00-00 No No Current 71610-016-53 71610001653 60 TABLET, FILM COATED in 1 BOTTLE (71610-016-53) 2020-05-05 0000-00-00 No No Current 71610-016-70 71610001670 120 TABLET, FILM COATED in 1 BOTTLE (71610-016-70) 2020-05-05 0000-00-00 No No Current 71610-016-92 71610001692 270 TABLET, FILM COATED in 1 BOTTLE (71610-016-92) 2017-12-27 0000-00-00 No No Current