38779-0395
- Product NDC
- 38779-0395
- 11-digit product format
- 387790395
- Labeler code
- 38779
- Product ID
- 38779-0395_43957d43-1dd3-eaa1-e063-6394a90a9d22
- Type
- BULK INGREDIENT
- Nonproprietary name
- Cyclobenzaprine Hydrochloride
- Dosage form
- POWDER
- Marketing category
- BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
- Marketing start
- 2012-03-29
- Substance
- CYCLOBENZAPRINE HYDROCHLORIDE
- Active strength
- 1 g/g
- Listing certified through
- 2026-12-31
- 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 | 38779-0395 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-21 | ||
| unfinished package | package | 38779-0395 | 38779-0395-1 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-21 | |
| unfinished package | package | 38779-0395 | 38779-0395-2 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-21 | |
| unfinished package | package | 38779-0395 | 38779-0395-3 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-21 | |
| unfinished package | package | 38779-0395 | 38779-0395-4 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-21 | |
| unfinished package | package | 38779-0395 | 38779-0395-5 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-21 | |
| unfinished package | package | 38779-0395 | 38779-0395-6 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-21 | |
| unfinished package | package | 38779-0395 | 38779-0395-7 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-21 | |
| unfinished package | package | 38779-0395 | 38779-0395-8 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-21 | |
| unfinished package | package | 38779-0395 | 38779-0395-9 | UNFINISHED | Active or certified unfinished drug listing | 2026-10-21 |
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 | 38779-0395-3 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 38779-0395-8 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 38779-0395-4 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 38779-0395-5 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 38779-0395-2 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 38779-0395-6 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 38779-0395-9 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 38779-0395-1 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 38779-0395-7 | 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 | 38779-0395-3 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 38779-0395-6 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 38779-0395-8 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 38779-0395-5 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 38779-0395-2 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 38779-0395-7 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 38779-0395-9 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 38779-0395-1 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 38779-0395-4 | 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 | 38779-0395-3 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 38779-0395-6 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 38779-0395-8 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 38779-0395-5 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 38779-0395-2 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 38779-0395-7 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 38779-0395-9 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 38779-0395-1 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 38779-0395-4 | 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 | 38779-0395-3 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 38779-0395-6 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 38779-0395-8 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 38779-0395-5 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 38779-0395-2 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 38779-0395-7 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 38779-0395-9 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 38779-0395-1 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 38779-0395-4 | 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 | 38779-0395-3 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 38779-0395-6 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 38779-0395-8 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 38779-0395-5 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 38779-0395-2 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 38779-0395-7 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 38779-0395-9 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 38779-0395-1 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 38779-0395-4 | 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 | 38779-0395-3 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 38779-0395-6 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 38779-0395-8 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 38779-0395-5 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 38779-0395-2 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 38779-0395-7 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 38779-0395-9 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 38779-0395-1 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 38779-0395-4 | f268b84574a6… | 26285f5ac5df… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | 1 g/g |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 38779-0395-1 | GM - Gram | 38779-0395 | a71b28a4-176b-453a-9f2d-a15a4887b2ec | 1 | 2015-05-05 |
| 38779-0395-2 | GM - Gram | 38779-0395 | 81e11f74-cf74-4637-a038-4c9072bae627 | 1 | 2013-08-02 |
| 38779-0395-3 | GM - Gram | 38779-0395 | 49abccea-d14b-45df-bb14-380a330457a5 | 1 | 2013-02-19 |
| 38779-0395-4 | GM - Gram | 38779-0395 | 27c70181-3a4d-4500-886b-f18c527a205f | 1 | 2013-02-19 |
| 38779-0395-5 | GM - Gram | 38779-0395 | 59f95efd-6290-4925-b5de-b06469bfaf5e | 1 | 2013-02-19 |
| 38779-0395-6 | GM - Gram | 38779-0395 | e1370152-749f-4a5d-9f8f-7a8af252a4d5 | 1 | 2015-05-05 |
| 38779-0395-7 | GM - Gram | 38779-0395 | c21bbee5-e884-4e45-8ef9-80b4740660e7 | 1 | 2014-09-03 |
| 38779-0395-8 | GM - Gram | 38779-0395 | 6b08cda8-8d17-4a59-8d71-239939b4e304 | 1 | 2013-02-19 |
| 38779-0395-9 | GM - Gram | 38779-0395 | c07196b1-5d44-4192-b2cb-22fd8445bd57 | 1 | 2013-02-19 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|---|---|---|---|---|
| 38779-0395-1 | 38779039501 | 3 g in 1 VIAL, GLASS (38779-0395-1) | 3 g | 29-MAR-12 | Current |
| 38779-0395-2 | 38779039502 | 5000 g in 1 PAIL (38779-0395-2) | 5000 g | 29-MAR-12 | Current |
| 38779-0395-3 | 38779039503 | 5 g in 1 VIAL, GLASS (38779-0395-3) | 5 g | 29-MAR-12 | Current |
| 38779-0395-4 | 38779039504 | 25 g in 1 JAR (38779-0395-4) | 25 g | 29-MAR-12 | Current |
| 38779-0395-5 | 38779039505 | 100 g in 1 JAR (38779-0395-5) | 100 g | 29-MAR-12 | Current |
| 38779-0395-6 | 38779039506 | .3 g in 1 VIAL, GLASS (38779-0395-6) | 29-MAR-12 | Current | |
| 38779-0395-7 | 38779039507 | 25000 g in 1 DRUM (38779-0395-7) | 25000 g | 29-MAR-12 | Current |
| 38779-0395-8 | 38779039508 | 500 g in 1 JAR (38779-0395-8) | 500 g | 29-MAR-12 | Current |
| 38779-0395-9 | 38779039509 | 1000 g in 1 JAR (38779-0395-9) | 1000 g | 29-MAR-12 | Current |