Carisoprodol

Product NDC: 72189-386
11-digit product format: 721890386
Labeler code: 72189
Product ID: 72189-386_2c4cda4e-be1d-b27b-e063-6394a90a8e19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carisoprodol
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA040792
Marketing category: ANDA
Marketing start: 2022-10-12
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: 2026-12-31
Current FDA listing: Yes

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-386-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-386-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-386-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-386-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-386-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-386-72	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040792-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	2009-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040792-002	CARISOPRODOL	250MG	TABLET / ORAL	AB	2016-11-08	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	A040792-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040792-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040792-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040792-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040792-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040792-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040792-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040792-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040792-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040792-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040792-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040792-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040792-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040792-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040792-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040792-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040792-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040792-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040792-001	AA	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040792-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040792-001	AA	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040792-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040792-001	AA	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040792-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040792-001	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040792-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040792-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040792-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040792-001	AA	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040792-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040792-001	AA	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040792-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040792-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040792-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040792-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040792-002	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Carisoprodol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARISOPRODOL	350 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
21925K482H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197446	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ead8294f-fd27-5c3d-e053-2a95a90a64af	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
780d53a1-1665-e26e-d112-85333c0c8a2e	Product name	5	20220516
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72189-386-30	Carisoprodol	30 in 1 BOTTLE	TABLET	30	3
72189-386-72	Carisoprodol	120 in 1 BOTTLE	TABLET	120	3
72189-386-90	Carisoprodol	90 in 1 BOTTLE	TABLET	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-386-30	EA - Each	72189-386	448e1504-7f9b-4d36-a9e8-692c058ef3c6	1	2022-12-07
72189-386-72	EA - Each	72189-386	ba4370d4-fe4d-467c-97c5-4e5071e0a46b	1	2022-11-07
72189-386-90	EA - Each	72189-386	e75120d1-b866-488f-a5e9-272c55db0ec0	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-386	CARISOPRODOL TABLET [DIRECT_RX]	3	Current NDC, Legacy NDC, 3 package rows	20250123_ead8294f-fd27-5c3d-e053-2a95a90a64af.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.

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 ndc (product): 72189-386
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197446	carisoprodol 350 MG Oral Tablet	PSN	ead8294f-fd27-5c3d-e053-2a95a90a64af	3
197446	carisoprodol 350 MG Oral Tablet	SCD	ead8294f-fd27-5c3d-e053-2a95a90a64af	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-386-30	72189038630	30 TABLET in 1 BOTTLE (72189-386-30)	30 tablet	2022-10-12	0000-00-00	No	No	Current
72189-386-72	72189038672	120 TABLET in 1 BOTTLE (72189-386-72)	120 tablet	2022-10-12	0000-00-00	No	No	Current
72189-386-90	72189038690	90 TABLET in 1 BOTTLE (72189-386-90)	90 tablet	2022-10-12	0000-00-00	No	No	Current