Cyclobenzaprine Hydrochloride
- Product NDC
- 50436-1101
- 11-digit product format
- 504361101
- Labeler code
- 50436
- Product ID
- 50436-1101_00d81aff-ba3f-4506-a651-23eba0183ab3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA078722
- Marketing category
- ANDA
- Marketing start
- 2015-03-25
- 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 product | product | 50436-1101 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 50436-1101 | 50436-1101-1 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50436-1101 | 50436-1101-2 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 50436-1101 | 50436-1101-3 | I | Inactivated by FDA | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50436-1101-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50436-1101-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50436-1101-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50436-1101-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50436-1101-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50436-1101-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50436-1101-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50436-1101-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50436-1101-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50436-1101-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50436-1101-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50436-1101-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50436-1101-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50436-1101-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50436-1101-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50436-1101-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50436-1101-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50436-1101-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50436-1101-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50436-1101-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50436-1101-3 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50436-1101-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50436-1101-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50436-1101-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50436-1101-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50436-1101-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50436-1101-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50436-1101-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50436-1101-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50436-1101-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50436-1101-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50436-1101-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50436-1101-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50436-1101-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50436-1101-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50436-1101-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50436-1101-2 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50436-1101-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50436-1101-3 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50436-1101-2 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50436-1101-1 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50436-1101-3 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50436-1101-2 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50436-1101-1 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50436-1101-3 | 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… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 51048710-225c-aa41-d0e7-eed095d02838 | Product name | 4 | 20250331 |
| c2c26dc9-7e16-fc02-7eba-6b46ed3515ee | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-1101-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0bd7-0266-e053-dadaa90a7c1a | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 50436-1101-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0bd7-0266-e053-dadaa90a7c1a | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
| 50436-1101-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0bd7-0266-e053-dadaa90a7c1a | CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-1101-1 | Cyclobenzaprine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 2 | |
| 50436-1101-2 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 2 | |
| 50436-1101-3 | Cyclobenzaprine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-1101-1 | EA - Each | 50436-1101 | 6e5a65cf-4d98-4368-8e11-2f45c3e99f10 | 1 | 2021-12-08 |
| 50436-1101-2 | EA - Each | 50436-1101 | 5e1744ca-5bc2-487d-ab27-e2b8a347914f | 1 | 2021-12-08 |
| 50436-1101-3 | EA - Each | 50436-1101 | 3674ea7c-ee4a-4a49-a762-35bacb960d4a | 1 | 2021-12-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-1101 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES] | 2 | Legacy NDC, 3 package rows | 20211023_81e02f60-2f10-4368-ad1b-e628f0016975.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.
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 828299 | cyclobenzaprine HCl 7.5 MG Oral Tablet | PSN | 81e02f60-2f10-4368-ad1b-e628f0016975 | 2 |
| 828299 | cyclobenzaprine hydrochloride 7.5 MG Oral Tablet | SCD | 81e02f60-2f10-4368-ad1b-e628f0016975 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50436-1101-1 | 50436110101 | 30 TABLET, FILM COATED in 1 BOTTLE (50436-1101-1) | 2021-10-12 | 0000-00-00 | No | No | Current |
| 50436-1101-2 | 50436110102 | 60 TABLET, FILM COATED in 1 BOTTLE (50436-1101-2) | 2021-10-12 | 0000-00-00 | No | No | Current |
| 50436-1101-3 | 50436110103 | 90 TABLET, FILM COATED in 1 BOTTLE (50436-1101-3) | 2021-10-12 | 0000-00-00 | No | No | Current |