Cyclobenzaprine Hydrochloride
- Product NDC
- 55700-762
- Requested package NDC
- 55700-762-01
- 11-digit product format
- 557000762
- Labeler code
- 55700
- Product ID
- 55700-762_e9960a9c-a7ce-4fd2-b12a-3f80ff18c5e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2019-06-14
- Marketing end
- 0000-00-00
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 55700-762 | 55700-762-01 | D | Discontinued by firm | 2026-08-07 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2008-05-12 | ||
| A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2008-05-12 | ||
| A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2008-05-12 |
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 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2008-05-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2008-05-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2008-05-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2008-05-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2008-05-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2008-05-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078722-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2008-05-12 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078722-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2008-05-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078722-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2008-05-12 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A078722-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078722-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078722-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078722-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078722-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078722-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078722-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078722-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078722-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078722-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078722-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078722-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078722-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078722-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078722-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078722-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078722-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078722-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078722-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078722-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078722-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078722-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078722-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078722-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078722-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078722-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078722-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078722-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078722-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078722-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078722-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078722-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078722-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078722-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078722-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078722-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078722-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078722-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078722-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078722-001 | AB | 1 | 5d02ea3f76ae… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 55700-762-01 | 2025-01-10 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 55700-762-30 | 2025-01-10 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 55700-762-60 | 2025-01-10 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 55700-762-90 | 2025-01-10 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 55700-762-01 | 2024-01-30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 55700-762-30 | 2024-01-30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 55700-762-60 | 2024-01-30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 55700-762-90 | 2024-01-30 | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-762-01 | EA - Each | 55700-762 | bde76e3a-14f8-4125-a04c-f8528a46f1ac | 1 | 2019-07-02 |
| 55700-762-30 | EA - Each | 55700-762 | f8f23f1b-e2bc-4b13-8514-1b0d3150bc9d | 1 | 2019-07-02 |
| 55700-762-60 | EA - Each | 55700-762 | a80b778f-4c71-4974-ac25-dd95e810f713 | 1 | 2019-07-02 |
| 55700-762-90 | EA - Each | 55700-762 | d0e72bea-ec64-4760-a5db-93612a023c1c | 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 | Proficient Rx LP | ae3a3f5c-fb64-4a43-be88-a2fc7c298ac1 | 2026-05-01 | Warnings, Adverse reactions | 078722 ANDA078722 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | a4cc7965-2ba8-42e8-8c5c-b90145a6598a | 2026-04-01 | Warnings, Adverse reactions | 078722 ANDA078722 |
| Cyclobenzaprine HCL | CYCLOBENZAPRINE HCL | PHOENIX RX LLC | 3a397e88-d267-feed-e063-6294a90a7710 | 2026-01-16 | Warnings, Adverse reactions | 078722 ANDA078722 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | A-S Medication Solutions | 81917fa4-c79c-46e2-bfbb-507fc0d7ed1b | 2025-12-04 | Warnings, Adverse reactions | 078722 ANDA078722 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | SA3, LLC | a4ae481f-9e47-470a-b4d1-5a33c0df8761 | 2025-06-23 | Warnings, Adverse reactions | 078722 ANDA078722 |
| Cyclobenzaprine HCL | CYCLOBENZAPRINE HCL | Advanced Rx of Tennessee, LLC | b062cb80-79a9-c5d8-e053-2a95a90aecfc | 2024-12-31 | Warnings, Adverse reactions | 078722 ANDA078722 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Quality Care Products LLC | 794d350b-6c88-41d5-b68b-3e2c57ee2a4f | 2024-12-17 | Warnings, Adverse reactions | 078722 ANDA078722 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 59f31ca3-1b28-4768-bb29-520f06f4a9f5 | 2024-08-20 | Warnings, Adverse reactions | 078722 ANDA078722 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 07e3ec53-f1f2-4231-aec6-1772a146ba88 | 2024-05-07 | Warnings, Adverse reactions | 078722 ANDA078722 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55700-762-01 | 55700076201 | 120 TABLET, FILM COATED in 1 BOTTLE (55700-762-01) | 2019-06-14 | 0000-00-00 | No | No | Current |