Carisoprodol

Product NDC: 70518-2800
Requested package NDC: 70518-2800-0
11-digit product format: 705182800
Labeler code: 70518
Product ID: 70518-2800_4f597625-7280-28c7-e063-6294a90ab0bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carisoprodol
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA040188
Marketing category: ANDA
Marketing start: 2020-06-25
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: 2027-12-31
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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2800	70518-2800-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040188-001	CARISOPRODOL	CARISOPRODOL	350MG	TABLET / ORAL	AA		1997-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040188-001	AA

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL		1997-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL		1997-03-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL		1997-03-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL		1997-03-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040188-001	CARISOPRODOL	350MG	TABLET / ORAL	AA	1997-03-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040188-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040188-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040188-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040188-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040188-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040188-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040188-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040188-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040188-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040188-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040188-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040188-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040188-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040188-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040188-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040188-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040188-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040188-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040188-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040188-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040188-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040188-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040188-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040188-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040188-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040188-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040188-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040188-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040188-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040188-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040188-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040188-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040188-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040188-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040188-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040188-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040188-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carisoprodol
Listing expiration: 2027-12-31

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
b83f7fd1-11e3-4e94-ae53-4637e892b372	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	Strength	SPL version
70518-2800-0	Carisoprodol	60 in 1 BOTTLE, PLASTIC	TABLET	60		14
70518-2800-1	Carisoprodol	90 in 1 BOTTLE, PLASTIC	TABLET	90		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2800-0	EA - Each	70518-2800	033f581f-d0af-4ea9-8128-968eb5a0498a	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2800	CARISOPRODOL TABLET [REMEDYREPACK INC.]	10	Current NDC, Legacy NDC, 2 package rows	20250403_b83f7fd1-11e3-4e94-ae53-4637e892b372.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carisoprodol	CARISOPRODOL	REMEDYREPACK INC.	b83f7fd1-11e3-4e94-ae53-4637e892b372	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188 ndc (package): 70518-2800-0 ndc (product): 70518-2800 ndc11 (package): 70518280000
CARISOPRODOL	CARISOPRODOL	Directrx	d5cc9f99-59ae-55db-e053-2995a90affb7	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	A-S Medication Solutions	6c15f559-c045-4271-86ef-e001aad39c33	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	A-S Medication Solutions	88f9b969-4225-49d6-9e4c-8c397ba7b50c	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	PD-Rx Pharmaceuticals, Inc.	4626a7a7-c433-4dab-8deb-e6e45de493a6	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	PD-Rx Pharmaceuticals, Inc.	9d251c26-c893-425a-b8ac-20c06e50e80c	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	f8aee817-c652-441e-b99a-8cbc4e6d06ef	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	95e13b8c-3558-43f0-b888-90978db878fb	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Bryant Ranch Prepack	acc7f959-55ac-4d9b-8ef4-4538378364e6	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Oxford Pharmaceuticals, LLC	03c3455f-e217-4a7e-908f-609333dc35fc	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Medsource Pharmaceuticals	125023cb-45c2-1685-e063-6394a90af089	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Aphena Pharma Solutions - Tennessee, LLC	2484de44-b36a-421c-a4d9-64c201694754	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Proficient Rx LP	b04fbd67-9ac5-4043-87e9-c3804d1e5d0c	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188
Carisoprodol	CARISOPRODOL	Aphena Pharma Solutions - Tennessee, LLC	2179f18b-df15-4bf6-a7c7-6d9960f49a42	2021-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040188 application number: ANDA040188

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	b83f7fd1-11e3-4e94-ae53-4637e892b372	14
197446	carisoprodol 350 MG Oral Tablet	SCD	b83f7fd1-11e3-4e94-ae53-4637e892b372	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2800-0	70518280000	60 TABLET in 1 BOTTLE, PLASTIC (70518-2800-0)	60 tablet	2020-06-25	0000-00-00	No	No	Current