Cyclobenzaprine Hydrochloride

Product NDC
0591-5658
Requested package NDC
0591-5658-05
11-digit product format
005915658
Labeler code
0591
Product ID
0591-5658_13578288-1fa1-4710-91a0-6e3026156d91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclobenzaprine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA071611
Marketing category
ANDA
Marketing start
1989-05-03
Marketing end
2022-08-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0591-56580591-5658-05DDiscontinued by firm2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071611-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03
A071611-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03
A071611-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A071611-001AB
A071611-002AB
A071611-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-02-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2006-02-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071611-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1989-05-038072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071611-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071611-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071611-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071611-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071611-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071611-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071611-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071611-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071611-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071611-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071611-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071611-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071611-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071611-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071611-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071611-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071611-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5658-01EA - Each0591-5658aeb4c268-0cf9-4799-948b-d92fb940792612012-07-24
0591-5658-05EA - Each0591-5658e31c61b2-19a9-4a67-af63-90bd32c9485812012-07-24
0591-5658-10EA - Each0591-5658faa7df86-578d-4f1c-83a0-55b3b9dfd4aa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]9
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]3
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]2
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
Cyclobenzaprine HydrochlorideACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CyclobenzaprineACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET [REDPHARM DRUG INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.1d9e34cc-eee9-4147-abf8-c810a80e39d22026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071611
application number: ANDA071611
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1ac77323-7526-a129-e063-6394a90a641b2024-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071611
application number: ANDA071611
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.f8dec4e2-3151-4a79-b194-a11a57ada0b62022-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071611
application number: ANDA071611

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828348cyclobenzaprine HCl 10 MG Oral TabletPSNcfba6fcb-f58d-4de0-b443-7a6ce3f554484
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDcfba6fcb-f58d-4de0-b443-7a6ce3f554484
828348cyclobenzaprine HCl 10 MG Oral TabletPSN59500ba3-b16e-46f9-a867-6c54f1f8fd6a3
828348cyclobenzaprine HCl 10 MG Oral TabletPSN3fb41bbb-ff27-22c6-e054-00144ff8d46c3
828348cyclobenzaprine HCl 10 MG Oral TabletPSN3d3179d3-e2f0-4d4f-aef6-dc18b26fd4a73
828320cyclobenzaprine HCl 5 MG Oral TabletPSN59500ba3-b16e-46f9-a867-6c54f1f8fd6a3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD3d3179d3-e2f0-4d4f-aef6-dc18b26fd4a73
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD3fb41bbb-ff27-22c6-e054-00144ff8d46c3
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD59500ba3-b16e-46f9-a867-6c54f1f8fd6a3
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD59500ba3-b16e-46f9-a867-6c54f1f8fd6a3
828348cyclobenzaprine HCl 10 MG Oral TabletPSN220ebc47-d310-4668-8b51-47a4981b46ef2
828348cyclobenzaprine HCl 10 MG Oral TabletPSN1d325ea3-fd3f-4cf7-9d07-d5144e7945f52
828320cyclobenzaprine HCl 5 MG Oral TabletPSN220ebc47-d310-4668-8b51-47a4981b46ef2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD220ebc47-d310-4668-8b51-47a4981b46ef2
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD1d325ea3-fd3f-4cf7-9d07-d5144e7945f52
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD220ebc47-d310-4668-8b51-47a4981b46ef2
828348cyclobenzaprine HCl 10 MG Oral TabletPSNc08a20e2-dfa1-43fd-a054-6ad3046859c71
828348cyclobenzaprine HCl 10 MG Oral TabletPSNbb207c2e-87b3-4d5d-896a-e7e4afe331241
828348cyclobenzaprine HCl 10 MG Oral TabletPSN1534e79c-12cf-493e-8034-c1083f900ff51
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4eddf137-fd00-43d0-96ed-16f057806d4e1
828348cyclobenzaprine HCl 10 MG Oral TabletPSN4636827c-a0cf-46e3-a682-08a19021be111
828348cyclobenzaprine HCl 10 MG Oral TabletPSN352f7cf7-c591-364b-e054-00144ff88e881
828320cyclobenzaprine HCl 5 MG Oral TabletPSN4eddf137-fd00-43d0-96ed-16f057806d4e1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4eddf137-fd00-43d0-96ed-16f057806d4e1
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD4636827c-a0cf-46e3-a682-08a19021be111
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDbb207c2e-87b3-4d5d-896a-e7e4afe331241
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCDc08a20e2-dfa1-43fd-a054-6ad3046859c71
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD352f7cf7-c591-364b-e054-00144ff88e881
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD1534e79c-12cf-493e-8034-c1083f900ff51
828320cyclobenzaprine hydrochloride 5 MG Oral TabletSCD4eddf137-fd00-43d0-96ed-16f057806d4e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-5658-0500591565805500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-5658-05) 1989-05-032022-08-31NoNoCurrent