CYCLOBENZAPRINE HYDROCHLORIDE
- Product NDC
- 71335-1089
- Requested package NDC
- 71335-1089-7
- 11-digit product format
- 713351089
- Labeler code
- 71335
- Product ID
- 71335-1089_fb51afd9-e542-4a23-9f67-f8a0e417a986
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CYCLOBENZAPRINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078218
- Marketing category
- ANDA
- Marketing start
- 2010-02-18
- 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
- 2023-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 71335-1089 | 71335-1089-7 | D | Discontinued by firm | 2026-08-03 |
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.
| 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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | |
| A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | |
| A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078218-001 | AB |
| A078218-002 | AB |
| A078218-003 | AB |
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.
| 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 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078218-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-06-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078218-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2020-11-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078218-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-04-18 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078218-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078218-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078218-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078218-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078218-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078218-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078218-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078218-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078218-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078218-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078218-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078218-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078218-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078218-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078218-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078218-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078218-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078218-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078218-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078218-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078218-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078218-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078218-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078218-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078218-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078218-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078218-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078218-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078218-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078218-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078218-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078218-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078218-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078218-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078218-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078218-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078218-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078218-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078218-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078218-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-1089-1 | EA - Each | 71335-1089 | a105502e-0cde-4f92-bebb-5d324f68af9b | 1 | 2019-07-02 |
| 71335-1089-3 | EA - Each | 71335-1089 | 94dadb17-9f1e-4f66-862c-56f841315791 | 1 | 2019-07-02 |
| 71335-1089-4 | EA - Each | 71335-1089 | f57dfa3f-e910-488b-bf8f-c566c33aee27 | 1 | 2019-07-02 |
| 71335-1089-5 | EA - Each | 71335-1089 | b6527fdb-7a3d-4cc9-bc4d-0f57c9ccfef9 | 1 | 2019-07-02 |
| 71335-1089-6 | EA - Each | 71335-1089 | 6cf93360-1f78-4527-b701-42c64b218d0c | 1 | 2019-07-02 |
| 71335-1089-7 | EA - Each | 71335-1089 | e1dfb0be-0183-4cca-b9e4-f11339cbf715 | 1 | 2019-07-02 |
| 71335-1089-9 | EA - Each | 71335-1089 | a2410bf8-3549-49b6-bdc6-7bea252f9b05 | 1 | 2019-07-02 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 390151d4-5fcb-46e2-92e6-de184827f43d | 2024-10-24 | Warnings, Adverse reactions | 078218 ANDA078218 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 31bb92f6-ec8c-4636-8b07-8814417fe78e | 2023-12-31 | Warnings, Adverse reactions | 078218 ANDA078218 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | 3cdde96c-9fc9-4698-872a-25c05318ecb5 | 2021-11-19 | Warnings, Adverse reactions | 078218 ANDA078218 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | 50aa421f-1d73-4b43-8528-2617ef2507dc | 2019-12-01 | Warnings, Adverse reactions | 078218 ANDA078218 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-1089-7 | 71335108907 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1089-7) | 2019-02-12 | 0000-00-00 | No | No | Current |