62991-1040
- Product NDC
- 62991-1040
- 11-digit product format
- 629911040
- Labeler code
- 62991
- Product ID
- 62991-1040_9f1d0e35-bb59-41f1-88f5-cd3da142ced0
- Type
- BULK INGREDIENT
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- POWDER
- Marketing category
- BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
- Marketing start
- 2011-09-27
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 1 g/g
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 62991-1040 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-15 | ||
| unfinished package | package | 62991-1040 | 62991-1040-1 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-15 | |
| unfinished package | package | 62991-1040 | 62991-1040-2 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-15 | |
| unfinished package | package | 62991-1040 | 62991-1040-5 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-15 | |
| unfinished package | package | 62991-1040 | 62991-1040-6 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-15 | |
| unfinished package | package | 62991-1040 | 62991-1040-7 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-15 | |
| unfinished package | package | 62991-1040 | 62991-1040-8 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-15 |
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 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 62991-1040-5 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 62991-1040-1 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 62991-1040-8 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 62991-1040-6 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 62991-1040-2 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 62991-1040-7 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 62991-1040-5 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 62991-1040-1 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 62991-1040-8 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 62991-1040-6 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 62991-1040-2 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 62991-1040-7 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 62991-1040-5 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 62991-1040-1 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 62991-1040-8 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 62991-1040-6 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 62991-1040-2 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 62991-1040-7 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 62991-1040-5 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 62991-1040-1 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 62991-1040-8 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 62991-1040-6 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 62991-1040-2 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 62991-1040-7 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 62991-1040-5 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 62991-1040-1 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 62991-1040-8 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 62991-1040-6 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 62991-1040-2 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 62991-1040-7 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 62991-1040-5 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 62991-1040-1 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 62991-1040-8 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 62991-1040-6 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 62991-1040-2 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 62991-1040-7 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 62991-1040-5 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 62991-1040-1 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 62991-1040-8 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 62991-1040-6 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 62991-1040-2 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 62991-1040-7 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 62991-1040-5 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 62991-1040-1 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 62991-1040-8 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 62991-1040-6 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 62991-1040-2 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 62991-1040-7 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 62991-1040-5 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 62991-1040-1 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 62991-1040-8 | 05c55d027831… | ca05dca9dc4c… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 1 g/g |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62991-1040-1 | GM - Gram | 62991-1040 | 9aeb6120-ce8f-4a0c-a914-5d701e7b2be3 | 1 | 2013-02-19 |
| 62991-1040-2 | GM - Gram | 62991-1040 | c920644a-b339-493c-97f0-dfd2bb111e3d | 1 | 2013-02-19 |
| 62991-1040-4 | GM - Gram | 62991-1040 | a0158d28-795d-4630-87e4-fcfa3216897f | 1 | 2013-03-03 |
| 62991-1040-5 | GM - Gram | 62991-1040 | 43f76550-207b-4a85-b27e-b25e15d05676 | 1 | 2013-02-19 |
| 62991-1040-6 | GM - Gram | 62991-1040 | 246c3071-61cb-4fa2-96b0-182e4cfdc97f | 1 | 2013-02-19 |
| 62991-1040-7 | GM - Gram | 62991-1040 | 4868d02a-9e8b-404f-94e4-e3eed6220262 | 1 | 2013-02-19 |
| 62991-1040-8 | GM - Gram | 62991-1040 | 55def7cc-3996-418d-94c6-a2cff2930407 | 1 | 2023-07-06 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|---|---|---|---|---|
| 62991-1040-1 | 62991104001 | 5 g in 1 JAR (62991-1040-1) | 5 g | 27-SEP-11 | Current |
| 62991-1040-2 | 62991104002 | 25 g in 1 JAR (62991-1040-2) | 25 g | 27-SEP-11 | Current |
| 62991-1040-5 | 62991104005 | 100 g in 1 JAR (62991-1040-5) | 100 g | 27-SEP-11 | Current |
| 62991-1040-6 | 62991104006 | 1000 g in 1 JAR (62991-1040-6) | 1000 g | 27-SEP-11 | Current |
| 62991-1040-7 | 62991104007 | 5000 g in 1 JAR (62991-1040-7) | 5000 g | 27-SEP-11 | Current |
| 62991-1040-8 | 62991104008 | 500 g in 1 JAR (62991-1040-8) | 500 g | 21-MAR-23 | Current |