Soma

Product NDC: 0037-2250
11-digit product format: 000372250
Labeler code: 0037
Product ID: 0037-2250_7272db18-d8cf-4bd0-ab9d-37e191a06f18
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carisoprodol
Dosage form: TABLET
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA011792
Marketing category: NDA
Marketing start: 2007-09-08
Substance: CARISOPRODOL
Active strength: 250 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N011792-001	SOMA	CARISOPRODOL	350MG	TABLET / ORAL	AA	RLD, Approved before 1982
N011792-003	SOMA	CARISOPRODOL	250MG	CAPSULE / ORAL		RLD, Approved before 1982
N011792-004	SOMA	CARISOPRODOL	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N011792-001	AA
N011792-004	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011792-003	SOMA	250MG	CAPSULE / ORAL		RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011792-004	SOMA	250MG	TABLET / ORAL	AB	RLD, RS	2007-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011792-001	SOMA	350MG	TABLET / ORAL	AA	RLD, Approved before 1982		`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N011792-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N011792-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011792-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011792-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011792-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N011792-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011792-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011792-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011792-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011792-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011792-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011792-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011792-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011792-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011792-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011792-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011792-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011792-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011792-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N011792-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011792-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011792-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011792-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011792-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011792-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011792-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011792-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N011792-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011792-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011792-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011792-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N011792-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011792-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N011792-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011792-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N011792-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011792-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N011792-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011792-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N011792-004	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARISOPRODOL	250 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197446	Internal RxNorm lookup
213695	Internal RxNorm lookup
730794	Internal RxNorm lookup
730918	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
6297cf20-830a-11dc-94c8-0002a5d5c51b	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
0037-2250-10	Soma	100 in 1 BOTTLE, PLASTIC	TABLET	100		20
0037-2250-30	Soma	30 in 1 BOTTLE, PLASTIC	TABLET	30		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0037-2250-10	EA - Each	0037-2250	48eda365-0e62-46bb-b5b0-59a250d57f5a	1	2012-07-24
0037-2250-30	EA - Each	0037-2250	db8ad2dd-76de-4ce3-873b-7292c0c114fb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	SOMA (CARISOPRODOL ) TABLET [MEDA PHARMACEUTICALS INC.]	9
CARISOPRODOL	ACTIVE MOIETY	21925K482H	SOMA (CARISOPRODOL ) TABLET [MEDA PHARMACEUTICALS INC.]	9
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	SOMA (CARISOPRODOL) TABLET [REBEL DISTRIBUTORS CORP]	1
CARISOPRODOL	ACTIVE INGREDIENT	21925K482H	SOMA (CARISOPRODOL) TABLET [STAT RX USA LLC]	1
CARISOPRODOL	ACTIVE MOIETY	21925K482H	SOMA (CARISOPRODOL) TABLET [REBEL DISTRIBUTORS CORP]	1
CARISOPRODOL	ACTIVE MOIETY	21925K482H	SOMA (CARISOPRODOL) TABLET [STAT RX USA LLC]	1
alginic acid	INACTIVE INGREDIENT	8C3Z4148WZ	SOMA (CARISOPRODOL) TABLET [STAT RX USA LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SOMA (CARISOPRODOL) TABLET [STAT RX USA LLC]	1
potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	SOMA (CARISOPRODOL) TABLET [STAT RX USA LLC]	1
tribasic calcium phosphate	INACTIVE INGREDIENT	91D9GV0Z28	SOMA (CARISOPRODOL) TABLET [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0037-2250	SOMA (CARISOPRODOL) TABLET [MEDA PHARMACEUTICALS INC.]	18	Current NDC, Legacy NDC, 2 package rows	20230719_6297cf20-830a-11dc-94c8-0002a5d5c51b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Soma	CARISOPRODOL	Viatris Specialty LLC	6297cf20-830a-11dc-94c8-0002a5d5c51b	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011792 application number: NDA011792 ndc (product): 0037-2250
Carisoprodol	CARISOPRODOL	Mylan Pharmaceuticals Inc.	7c9184c0-7a2e-11df-8c8d-0002a5d5c51b	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 011792 application number: NDA011792

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
730794	carisoprodol 250 MG Oral Tablet	PSN	6297cf20-830a-11dc-94c8-0002a5d5c51b	20
197446	carisoprodol 350 MG Oral Tablet	PSN	6297cf20-830a-11dc-94c8-0002a5d5c51b	20
730918	Soma 250 MG Oral Tablet	PSN	6297cf20-830a-11dc-94c8-0002a5d5c51b	20
213695	Soma 350 MG Oral Tablet	PSN	6297cf20-830a-11dc-94c8-0002a5d5c51b	20
730918	carisoprodol 250 MG Oral Tablet [Soma]	SBD	6297cf20-830a-11dc-94c8-0002a5d5c51b	20
213695	carisoprodol 350 MG Oral Tablet [Soma]	SBD	6297cf20-830a-11dc-94c8-0002a5d5c51b	20
730794	carisoprodol 250 MG Oral Tablet	SCD	6297cf20-830a-11dc-94c8-0002a5d5c51b	20
197446	carisoprodol 350 MG Oral Tablet	SCD	6297cf20-830a-11dc-94c8-0002a5d5c51b	20
730918	Soma 250 MG Oral Tablet	SY	6297cf20-830a-11dc-94c8-0002a5d5c51b	20
213695	Soma 350 MG Oral Tablet	SY	6297cf20-830a-11dc-94c8-0002a5d5c51b	20
730794	carisoprodol 250 MG Oral Tablet	PSN	6543c6ba-852e-40fb-b7ec-1331b9c83656	1
730794	carisoprodol 250 MG Oral Tablet	PSN	b38e1880-9152-4ca4-93e3-b9f6d14db958	1
730918	Soma 250 MG Oral Tablet	PSN	6543c6ba-852e-40fb-b7ec-1331b9c83656	1
730918	Soma 250 MG Oral Tablet	PSN	b38e1880-9152-4ca4-93e3-b9f6d14db958	1
730918	carisoprodol 250 MG Oral Tablet [Soma]	SBD	6543c6ba-852e-40fb-b7ec-1331b9c83656	1
730918	carisoprodol 250 MG Oral Tablet [Soma]	SBD	b38e1880-9152-4ca4-93e3-b9f6d14db958	1
730794	carisoprodol 250 MG Oral Tablet	SCD	b38e1880-9152-4ca4-93e3-b9f6d14db958	1
730794	carisoprodol 250 MG Oral Tablet	SCD	6543c6ba-852e-40fb-b7ec-1331b9c83656	1
730918	Soma 250 MG Oral Tablet	SY	6543c6ba-852e-40fb-b7ec-1331b9c83656	1
730918	Soma 250 MG Oral Tablet	SY	b38e1880-9152-4ca4-93e3-b9f6d14db958	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0037-2250-10	00037225010	100 TABLET in 1 BOTTLE, PLASTIC (0037-2250-10)	100 tablet	2007-09-08	0000-00-00	No	No	Current
0037-2250-30	00037225030	30 TABLET in 1 BOTTLE, PLASTIC (0037-2250-30)	30 tablet	2007-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Soma	Viatris Specialty LLC	2025-08-29	HUMAN PRESCRIPTION DRUG LABEL	20
SOMA	STAT RX USA LLC	2011-07-07	HUMAN PRESCRIPTION DRUG LABEL	1
Soma	Rebel Distributors Corp	2010-12-01	HUMAN PRESCRIPTION DRUG LABEL	1