Home NDC 43063-494 Cyclobenzaprine Hydrochloride
Product NDC 43063-494
11-digit product format 430630494
Labeler code 43063
Product ID 43063-494_4138b440-6586-92bc-e063-6394a90a3a3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyclobenzaprine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA078048
Marketing category ANDA
Marketing start 2014-07-31
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 · 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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43063-494-01 Cyclobenzaprine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 25 43063-494-10 Cyclobenzaprine Hydrochloride 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 25 43063-494-14 Cyclobenzaprine Hydrochloride 14 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 14 25 43063-494-15 Cyclobenzaprine Hydrochloride 15 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 15 25 43063-494-20 Cyclobenzaprine Hydrochloride 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 25 43063-494-21 Cyclobenzaprine Hydrochloride 21 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 21 25 43063-494-30 Cyclobenzaprine Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 25 43063-494-60 Cyclobenzaprine Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 25 43063-494-82 Cyclobenzaprine Hydrochloride 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 25 43063-494-90 Cyclobenzaprine Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 25 43063-494-95 Cyclobenzaprine Hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 25
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 [PD-RX PHARMACEUTICALS, INC.] 6 CYCLOBENZAPRINE ACTIVE MOIETY 69O5WQQ5TI CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43063-494 CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 24 Current NDC, Legacy NDC, 11 package rows 20240713_e505c31b-4618-4e4f-8da6-92030464004f.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 ndc (product): 43063-494 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 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 43063-494-01 43063049401 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-01) 2018-12-05 0000-00-00 No No Current 43063-494-10 43063049410 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-10) 2014-07-31 0000-00-00 No No Current 43063-494-14 43063049414 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-14) 2014-07-31 0000-00-00 No No Current 43063-494-15 43063049415 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-15) 2014-07-31 0000-00-00 No No Current 43063-494-20 43063049420 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-20) 2019-09-04 0000-00-00 No No Current 43063-494-21 43063049421 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-21) 2014-07-31 0000-00-00 No No Current 43063-494-30 43063049430 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-30) 2014-07-31 0000-00-00 No No Current 43063-494-60 43063049460 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-60) 2014-07-31 0000-00-00 No No Current 43063-494-82 43063049482 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-82) 2018-12-05 0000-00-00 No No Current 43063-494-90 43063049490 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-90) 2014-07-31 0000-00-00 No No Current 43063-494-95 43063049495 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-494-95) 2018-12-04 0000-00-00 No No Current