Cyclobenzaprine Hydrochloride
- Product NDC
- 52959-042
- 11-digit product format
- 529590042
- Labeler code
- 52959
- Product ID
- 52959-042_5da7b877-db35-d9af-e053-2a91aa0aa7a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- H. J Harkins Company Inc
- Application
- ANDA077797
- Marketing category
- ANDA
- Marketing start
- 2017-01-03
- 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
- 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 | 52959-042 | I | Inactivated by FDA | 2026-08-11 | ||
| excluded package | package | 52959-042 | 52959-042-00 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-042 | 52959-042-06 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-042 | 52959-042-10 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-042 | 52959-042-15 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-042 | 52959-042-20 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-042 | 52959-042-21 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-042 | 52959-042-30 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-042 | 52959-042-60 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 52959-042 | 52959-042-90 | I | Inactivated by FDA | 2026-08-11 |
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.
| 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 | 52959-042-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-042-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-042-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-042-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-042-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-042-06 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-042-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-042-00 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52959-042-21 | 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 | 52959-042-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-042-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-042-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-042-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-042-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-042-06 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-042-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-042-00 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52959-042-21 | 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 | 52959-042-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-042-90 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-042-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-042-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-042-15 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-042-06 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-042-60 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-042-00 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52959-042-21 | 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 | 52959-042-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-042-90 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-042-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-042-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-042-15 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-042-06 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-042-60 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-042-00 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52959-042-21 | 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 | 52959-042-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-042-90 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-042-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-042-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-042-15 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-042-06 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-042-60 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-042-00 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52959-042-21 | 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 | 52959-042-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-042-90 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-042-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-042-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-042-15 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-042-06 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-042-60 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-042-00 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52959-042-21 | cdf11ea48f46… | ba0047e9e063… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | |
| A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077797-001 | AB |
| A077797-002 | 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 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 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 | A077797-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077797-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077797-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077797-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077797-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077797-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077797-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077797-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077797-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077797-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077797-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077797-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077797-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077797-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077797-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077797-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077797-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077797-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077797-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077797-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077797-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077797-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077797-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077797-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077797-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077797-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077797-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077797-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077797-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077797-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077797-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077797-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077797-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077797-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077797-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077797-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077797-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077797-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077797-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077797-002 | AB | 1 | 782e0a99824c… |
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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52959-042-60 | Therabenzaprine-90 | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 10 mg | 9 |
| 52959-042-60 | Therabenzaprine-60 | 60 in 1 BOTTLE | TABLET | 60 | 10 mg | 4 |
| 52959-042-00 | Cyclobenzaprine Hydrochloride | 100 in 1 CONTAINER | TABLET, FILM COATED | 100 | 1 | |
| 52959-042-06 | Cyclobenzaprine Hydrochloride | 6 in 1 CONTAINER | TABLET, FILM COATED | 6 | 1 | |
| 52959-042-10 | Cyclobenzaprine Hydrochloride | 10 in 1 CONTAINER | TABLET, FILM COATED | 10 | 1 | |
| 52959-042-15 | Cyclobenzaprine Hydrochloride | 15 in 1 CONTAINER | TABLET, FILM COATED | 15 | 1 | |
| 52959-042-20 | Cyclobenzaprine Hydrochloride | 20 in 1 CONTAINER | TABLET, FILM COATED | 20 | 1 | |
| 52959-042-21 | Cyclobenzaprine Hydrochloride | 21 in 1 CONTAINER | TABLET, FILM COATED | 21 | 1 | |
| 52959-042-30 | Cyclobenzaprine Hydrochloride | 30 in 1 CONTAINER | TABLET, FILM COATED | 30 | 1 | |
| 52959-042-60 | Cyclobenzaprine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 1 | |
| 52959-042-90 | Cyclobenzaprine Hydrochloride | 90 in 1 CONTAINER | TABLET, FILM COATED | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52959-042-00 | EA - Each | 52959-042 | b8ff0445-e08a-4db5-8447-02251474dfcc | 1 | 2017-12-14 |
| 52959-042-10 | EA - Each | 52959-042 | bfb88d68-5f3e-4566-8d47-3713eea1357c | 1 | 2017-12-14 |
| 52959-042-15 | EA - Each | 52959-042 | 58bdae87-3230-4418-8a70-1cc4298d664f | 1 | 2017-12-14 |
| 52959-042-20 | EA - Each | 52959-042 | 63cd6ad6-041a-4459-9c52-b4675e59ffd0 | 1 | 2017-12-14 |
| 52959-042-21 | EA - Each | 52959-042 | a549ba4a-edb2-4338-b512-3eec42168a4f | 1 | 2017-12-14 |
| 52959-042-30 | EA - Each | 52959-042 | 6fdd8a16-98e8-4e84-9072-81302825a3e0 | 1 | 2017-12-14 |
| 52959-042-60 | EA - Each | 52959-042 | 9eb41ad3-5cd0-4de5-9d1c-0a04e5229a36 | 1 | 2017-12-14 |
| 52959-042-90 | EA - Each | 52959-042 | d86df2b7-0887-46b8-b0e4-566a40752254 | 1 | 2017-12-14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52959-042 | THERABENZAPRINE-90 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 9 | Legacy NDC | 20110815_6f49de96-1090-46bc-b7bf-0dc70f7d9530.zip |
| 52959-042 | THERABENZAPRINE-60 (CYCLOBENZAPRINE HYDROCHLORIDE, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC] | 4 | Legacy NDC | 20110812_b016f51f-82c2-498d-83f1-51e01505a0ae.zip |
| 52959-042 | CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [H. J HARKINS COMPANY INC] | 1 | Legacy NDC, 9 package rows | 20171114_5da7b877-db34-d9af-e053-2a91aa0aa7a0.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 | Golden State Medical Supply, Inc. | 15c0c7aa-8c54-4040-a1bf-2a7b421ad33f | 2025-12-11 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 59b428fa-5013-4b2b-872f-16ba4a9d4f5d | 2025-05-01 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9161cb5e-63e5-41d7-9bde-66c7b7b7a2f3 | 2025-05-01 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3aaa4808-7f2d-410c-9b6c-193549ec0845 | 2025-04-30 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7829a96a-3668-4d88-90e9-0ecbedb2bd7e | 2025-04-30 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3baeda95-d098-437a-b360-87a9c3f3fd9b | 2025-04-30 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | aa29e260-fb77-415a-a505-3230d30c8945 | 2025-02-10 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | afcad582-ab59-4f70-e053-2a95a90a04e4 | 2024-12-31 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 4c51f56b-33c3-4611-bba8-876d9dde7aff | 2024-11-27 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 90c7a982-6442-4241-a60b-b5dfab2abb71 | 2024-01-31 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | c86303a0-7c8b-415e-acac-1070b7d0d445 | 2024-01-15 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 68db3c3b-8da1-4852-90b0-3172f842aa02 | 2023-03-02 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Solco Healthcare U.S., LLC | f558863b-ea3f-4e4b-85e9-edb2573e7151 | 2022-08-22 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | be5201bc-e1f1-41af-be46-4a8fbb223b86 | 2020-05-27 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | 571fbb2b-24e0-4de3-8cfa-c267fc397b6c | 2019-10-01 | Warnings, Adverse reactions | 077797 ANDA077797 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 828348 | cyclobenzaprine HCl 10 MG Oral Tablet | PSN | 6f49de96-1090-46bc-b7bf-0dc70f7d9530 | 9 |
| 828348 | cyclobenzaprine hydrochloride 10 MG Oral Tablet | SCD | 6f49de96-1090-46bc-b7bf-0dc70f7d9530 | 9 |
| 828348 | cyclobenzaprine HCl 10 MG Oral Tablet | PSN | b016f51f-82c2-498d-83f1-51e01505a0ae | 4 |
| 828348 | cyclobenzaprine hydrochloride 10 MG Oral Tablet | SCD | b016f51f-82c2-498d-83f1-51e01505a0ae | 4 |
| 828348 | cyclobenzaprine HCl 10 MG Oral Tablet | PSN | 5da7b877-db34-d9af-e053-2a91aa0aa7a0 | 1 |
| 828348 | cyclobenzaprine hydrochloride 10 MG Oral Tablet | SCD | 5da7b877-db34-d9af-e053-2a91aa0aa7a0 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 52959-042-00 | 52959004200 | 100 in 1 CONTAINER | Historical |
| 52959-042-06 | 52959004206 | 6 in 1 CONTAINER | Historical |
| 52959-042-10 | 52959004210 | 10 in 1 CONTAINER | Historical |
| 52959-042-15 | 52959004215 | 15 in 1 CONTAINER | Historical |
| 52959-042-20 | 52959004220 | 20 in 1 CONTAINER | Historical |
| 52959-042-21 | 52959004221 | 21 in 1 CONTAINER | Historical |
| 52959-042-30 | 52959004230 | 30 in 1 CONTAINER | Historical |
| 52959-042-60 | 52959004260 | 60 in 1 BOTTLE | Historical |
| 52959-042-90 | 52959004290 | 90 in 1 CONTAINER | Historical |