AMRIX
- Product NDC
- 50090-1101
- 11-digit product format
- 500901101
- Labeler code
- 50090
- Product ID
- 50090-1101_89bb20a0-9a04-4800-b335-ced9b9401ea8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA021777
- Marketing category
- NDA
- Marketing start
- 2007-10-02
- Marketing end
- 0000-00-00
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 | 50090-1101 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 50090-1101 | 50090-1101-2 | 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 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 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 | 50090-1101-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021777-001 | AMRIX | CYCLOBENZAPRINE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 |
| N021777-002 | AMRIX | CYCLOBENZAPRINE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021777-001 | AB |
| N021777-002 | 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 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021777-001 | AMRIX | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2007-02-01 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021777-002 | AMRIX | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2007-02-01 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021777-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021777-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021777-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021777-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021777-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021777-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021777-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021777-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021777-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021777-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021777-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021777-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021777-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021777-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021777-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021777-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021777-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021777-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021777-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021777-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021777-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021777-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021777-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021777-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021777-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021777-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021777-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021777-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021777-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021777-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021777-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021777-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021777-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021777-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021777-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021777-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021777-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021777-002 | AB | 1 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-001 | 7544372 | 2023-11-14 | U-979 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-001 | 7790199 | 2023-11-14 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-001 | 7820203 | 2023-11-14 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-001 | 7829121 | 2023-11-14 | U-1088 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-001 | 8877245 | 2023-11-14 | U-979 | 2018-06-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-001 | 9375410 | 2023-11-14 | U-1088 | 2016-07-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-001 | 9399025 | 2023-11-14 | U-979 | Drug product | 2016-08-04 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-001 | 7387793 | 2025-02-26 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-002 | 7544372 | 2023-11-14 | U-979 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-002 | 7790199 | 2023-11-14 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-002 | 7820203 | 2023-11-14 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-002 | 7829121 | 2023-11-14 | U-1088 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-002 | 8877245 | 2023-11-14 | U-979 | 2018-06-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-002 | 9375410 | 2023-11-14 | U-1088 | 2016-07-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-002 | 9399025 | 2023-11-14 | U-979 | Drug product | 2016-08-04 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021777-002 | 7387793 | 2025-02-26 | Drug product | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021777-001 | 7544372 | 2023-11-14 | U-979 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021777-001 | 7790199 | 2023-11-14 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021777-001 | 7820203 | 2023-11-14 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021777-001 | 7829121 | 2023-11-14 | U-1088 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021777-001 | 8877245 | 2023-11-14 | U-979 | 2018-06-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021777-001 | 9375410 | 2023-11-14 | U-1088 | 2016-07-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021777-001 | 9399025 | 2023-11-14 | U-979 | Drug product | 2016-08-04 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021777-001 | 7387793 | 2025-02-26 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021777-002 | 7544372 | 2023-11-14 | U-979 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021777-002 | 7790199 | 2023-11-14 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021777-002 | 7820203 | 2023-11-14 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021777-002 | 7829121 | 2023-11-14 | U-1088 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021777-002 | 8877245 | 2023-11-14 | U-979 | 2018-06-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021777-002 | 9375410 | 2023-11-14 | U-1088 | 2016-07-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021777-002 | 9399025 | 2023-11-14 | U-979 | Drug product | 2016-08-04 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021777-002 | 7387793 | 2025-02-26 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021777-001 | 7544372 | 2023-11-14 | U-979 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021777-001 | 7790199 | 2023-11-14 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021777-001 | 7820203 | 2023-11-14 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021777-001 | 7829121 | 2023-11-14 | U-1088 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021777-001 | 8877245 | 2023-11-14 | U-979 | 2018-06-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021777-001 | 9375410 | 2023-11-14 | U-1088 | 2016-07-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021777-001 | 9399025 | 2023-11-14 | U-979 | Drug product | 2016-08-04 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021777-001 | 7387793 | 2025-02-26 | Drug product | 4b0b4de00fa7… |
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 | Preferred Pharmaceuticals Inc. | 96b650d8-4ad5-42af-aa8c-aa0ac25abfb5 | 2026-03-17 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | REMEDYREPACK INC. | 30e61110-5bc8-4134-8456-538558479735 | 2025-09-30 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | REMEDYREPACK INC. | 3175d24d-e8a0-4f14-bed9-a60ad59ac7e7 | 2025-09-26 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 8a8c9479-b3ab-453a-bd8a-deaf38000742 | 2025-09-24 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Doc Rx | d4457b8c-fff8-4c19-8d5a-a667161e5446 | 2025-09-04 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PHOENIX RX LLC | 3a116427-c427-c3bc-e063-6294a90ac539 | 2025-07-21 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | dd546a0e-e5be-4232-8ad8-fcd7d5f9a903 | 2025-05-27 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 2169667d-4f4b-472d-929b-8a0bcbddbe9c | 2025-03-26 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine HCL ER | CYCLOBENZAPRINE HCL ER | Direct_Rx | e4a3383a-7b30-25b7-e053-2995a90a341b | 2025-01-22 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine HCL ER | CYCLOBENZAPRINE HCL ER | Direct_Rx | ed0b9acc-132f-64c0-e053-2995a90a198c | 2025-01-22 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine HCL ER | CYCLOBENZAPRINE HCL | Advanced Rx Pharmacy of Tennessee, LLC | f8360da5-f1d3-1d89-e053-6294a90ad31c | 2024-12-31 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 259fb05a-4f45-9c8e-e063-6294a90a4484 | 2024-10-29 | Warnings, Adverse reactions | 021777 NDA021777 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | ca74d27a-f7c6-462d-a913-1cfa061bd8f3 | 2024-05-31 | Warnings, Adverse reactions | 021777 NDA021777 |
| AMRIX | CYCLOBENZAPRINE HYDROCHLORIDE | Cephalon, LLC | 3902123b-1365-ac3c-0934-afff9eeeb1bd | 2024-04-30 | Warnings, Adverse reactions | 021777 NDA021777 |