carisoprodol

Product NDC: 64980-381
Requested package NDC: 64980-381-50
11-digit product format: 649800381
Labeler code: 64980
Product ID: 64980-381_c588a816-0c7f-4b75-82f7-6dce5f71ed4d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carisoprodol
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharmaceuticals, Inc.
Application: ANDA040792
Marketing category: ANDA
Marketing start: 2009-08-06
Marketing end: 0000-00-00
Substance: CARISOPRODOL
Active strength: 350 mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
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.

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
excluded package	package	64980-381	64980-381-50	D	Discontinued by firm		2026-08-17

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 · 12 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040792-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		2009-08-06
A040792-002	CARISOPRODOL	CARISOPRODOL	250MG	TABLET / ORAL	AB		2016-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040792-001	AA
A040792-002	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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040792-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040792-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040792-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040792-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040792-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040792-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040792-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040792-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040792-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040792-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040792-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040792-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040792-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040792-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040792-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040792-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040792-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040792-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040792-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040792-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040792-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040792-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040792-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040792-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040792-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040792-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040792-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040792-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040792-002	AB	1	`bb7c543d1eb4…`

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.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
carisoprodol	CARISOPRODOL	REMEDYREPACK INC.	eebb9409-e333-4b9f-8059-6588c35ab578	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	NuCare Pharmaceuticals,Inc.	fd03c357-b199-c2b2-e053-6294a90abe2e	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
Carisoprodol	CARISOPRODOL	Direct_Rx	ead8294f-fd27-5c3d-e053-2a95a90a64af	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	Asclemed USA, Inc.	301f5e6a-54e1-4885-b9cb-de475de59b22	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	b72ac75b-8c7c-4ec4-a7fa-b9c1a18f644c	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	Aurobindo Pharma Limited	79637c7b-fe7b-436c-892b-6c36abfdcacc	2024-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792
carisoprodol	CARISOPRODOL	Rising Pharma Holdings, Inc.	4d2470cb-7a5d-45f0-b005-534458833d91	2024-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040792 application number: ANDA040792

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
21925K482H	CARISOPRODOL	78-44-4	CARISOPRODOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-381-50	64980038150	500 TABLET in 1 BOTTLE (64980-381-50)	500 tablet	2009-08-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
carisoprodol	Rising Pharmaceuticals, Inc. \| Aurobindo Pharma Limited	2022-10-29	Human Prescription Drug Label	3