Carisoprodol

Product NDC: 72789-190
11-digit product format: 727890190
Labeler code: 72789
Product ID: 72789-190_2d6a0cc6-8c41-6b0a-e063-6394a90a0c11
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carisoprodol
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA040188
Marketing category: ANDA
Marketing start: 2020-01-20
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

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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (product): 72789-190
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

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
9d251c26-c893-425a-b8ac-20c06e50e80c	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
72789-190-14	Carisoprodol	14 in 1 BOTTLE, PLASTIC	TABLET	14	8
72789-190-30	Carisoprodol	30 in 1 BOTTLE, PLASTIC	TABLET	30	8
72789-190-98	Carisoprodol	120 in 1 BOTTLE, PLASTIC	TABLET	120	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-190-14	EA - Each	72789-190	a11918ec-908e-4cf7-9b50-ac8697d23e22	1	2021-07-15
72789-190-30	EA - Each	72789-190	35030ca8-d7f4-4817-8e15-c65a76dc7c57	1	2021-07-15
72789-190-98	EA - Each	72789-190	49a5eb58-f9c2-48eb-9f47-adf8536b105b	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-190	CARISOPRODOL TABLET [PD-RX PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 3 package rows	20250207_9d251c26-c893-425a-b8ac-20c06e50e80c.zip

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	9d251c26-c893-425a-b8ac-20c06e50e80c	8
197446	carisoprodol 350 MG Oral Tablet	SCD	9d251c26-c893-425a-b8ac-20c06e50e80c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-190-14	72789019014	14 TABLET in 1 BOTTLE, PLASTIC (72789-190-14)	14 tablet	2021-05-26	0000-00-00	No	No	Current
72789-190-30	72789019030	30 TABLET in 1 BOTTLE, PLASTIC (72789-190-30)	30 tablet	2021-05-20	0000-00-00	No	No	Current
72789-190-98	72789019098	120 TABLET in 1 BOTTLE, PLASTIC (72789-190-98)	120 tablet	2022-08-03	0000-00-00	No	No	Current