62991-1040-8

Product NDC: 62991-1040
Requested package NDC: 62991-1040-8
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
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.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`

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 table
Ingredient	Strength
CYCLOBENZAPRINE HYDROCHLORIDE	1 g/g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0VE05JYS2P	CYCLOBENZAPRINE HYDROCHLORIDE	6202-23-9	CYCLOBENZAPRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
62991-1040-8	62991104008	500 g in 1 JAR (62991-1040-8)	500 g	21-MAR-23	Current