INPEFA

Product NDC: 70183-241
11-digit product format: 701830241
Labeler code: 70183
Product ID: 70183-241_2179079d-1c89-44b3-9b9c-2001d46310a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sotagliflozin
Dosage form: TABLET
Route: ORAL
Labeler: Lexicon Pharmaceuticals, Inc.
Application: NDA216203
Marketing category: NDA
Marketing start: 2023-05-26
Substance: SOTAGLIFLOZIN
Active strength: 400 mg/1
Pharmacologic classes: P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N216203-001	INPEFA	SOTAGLIFLOZIN	200MG	TABLET / ORAL		RLD	2023-05-26
N216203-002	INPEFA	SOTAGLIFLOZIN	400MG	TABLET / ORAL		RLD, RS	2023-05-26

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216203-001	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22
N216203-001	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22
N216203-001	8217156	2030-10-07		Drug substance, Drug product	2023-06-22
N216203-002	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22
N216203-002	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22
N216203-002	8217156	2030-10-07		Drug substance, Drug product	2023-06-22

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216203-001	NCE	2028-05-26
N216203-002	NCE	2028-05-26

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 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216203-001	INPEFA	200MG	TABLET / ORAL	RLD	2023-05-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216203-002	INPEFA	400MG	TABLET / ORAL	RLD, RS	2023-05-26	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 138 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N216203-001	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216203-001	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216203-001	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216203-002	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216203-002	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216203-002	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216203-001	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216203-001	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216203-001	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216203-002	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216203-002	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216203-002	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216203-001	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216203-001	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216203-001	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216203-002	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216203-002	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216203-002	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216203-001	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216203-001	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216203-001	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216203-002	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216203-002	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216203-002	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216203-001	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216203-001	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216203-001	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216203-002	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216203-002	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216203-002	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216203-001	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216203-001	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216203-001	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216203-002	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216203-002	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216203-002	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216203-001	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216203-001	8476413	2028-05-29	U-3628	Drug substance, Drug product	2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216203-001	8217156	2030-10-07		Drug substance, Drug product	2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216203-002	7781577	2028-05-04	U-3628	Drug substance, Drug product	2023-06-22	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N216203-001	NCE	2028-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216203-002	NCE	2028-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216203-001	NCE	2028-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216203-002	NCE	2028-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216203-001	NCE	2028-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216203-002	NCE	2028-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216203-001	NCE	2028-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216203-002	NCE	2028-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216203-001	NCE	2028-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216203-002	NCE	2028-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216203-001	NCE	2028-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216203-002	NCE	2028-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216203-001	NCE	2028-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216203-002	NCE	2028-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216203-001	NCE	2028-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216203-002	NCE	2028-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216203-001	NCE	2028-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216203-002	NCE	2028-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216203-001	NCE	2028-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216203-002	NCE	2028-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216203-001	NCE	2028-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216203-002	NCE	2028-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216203-001	NCE	2028-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216203-002	NCE	2028-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216203-001	NCE	2028-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216203-002	NCE	2028-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216203-001	NCE	2028-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216203-002	NCE	2028-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216203-001	NCE	2028-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216203-002	NCE	2028-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216203-001	NCE	2028-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216203-002	NCE	2028-05-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216203-001	NCE	2028-05-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216203-002	NCE	2028-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216203-001	NCE	2028-05-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216203-002	NCE	2028-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216203-001	NCE	2028-05-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216203-002	NCE	2028-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216203-001	NCE	2028-05-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216203-002	NCE	2028-05-26	`a72a2bbeb626…`

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: INPEFA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SOTAGLIFLOZIN	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6B4ZBS263Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2638683	Internal RxNorm lookup
2638689	Internal RxNorm lookup
2638691	Internal RxNorm lookup
2638693	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
1a46614e-05f6-421a-b6f4-d6f8760d643a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c756bac4-3307-406f-929a-2842e7f1e9e6	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70183-241-30	INPEFA	30 in 1 BOTTLE	TABLET	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70183-241-30	EA - Each	70183-241	8eabf929-9a03-4386-bf67-1f655695fee7	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70183-241	INPEFA (SOTAGLIFLOZIN) TABLET [LEXICON PHARMACEUTICALS, INC.]	9	Current NDC, 1 package rows	20240130_1a46614e-05f6-421a-b6f4-d6f8760d643a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INPEFA	SOTAGLIFLOZIN	Lexicon Pharmaceuticals, Inc.	1a46614e-05f6-421a-b6f4-d6f8760d643a	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216203 application number: NDA216203 ndc (product): 70183-241

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6B4ZBS263Y	SOTAGLIFLOZIN	1018899-04-1	SOTAGLIFLOZIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2638689	inpefa 200 MG Oral Tablet	PSN	1a46614e-05f6-421a-b6f4-d6f8760d643a	10
2638693	inpefa 400 MG Oral Tablet	PSN	1a46614e-05f6-421a-b6f4-d6f8760d643a	10
2638683	sotagliflozin 200 MG Oral Tablet	PSN	1a46614e-05f6-421a-b6f4-d6f8760d643a	10
2638691	sotagliflozin 400 MG Oral Tablet	PSN	1a46614e-05f6-421a-b6f4-d6f8760d643a	10
2638689	sotagliflozin 200 MG Oral Tablet [Inpefa]	SBD	1a46614e-05f6-421a-b6f4-d6f8760d643a	10
2638693	sotagliflozin 400 MG Oral Tablet [Inpefa]	SBD	1a46614e-05f6-421a-b6f4-d6f8760d643a	10
2638683	sotagliflozin 200 MG Oral Tablet	SCD	1a46614e-05f6-421a-b6f4-d6f8760d643a	10
2638691	sotagliflozin 400 MG Oral Tablet	SCD	1a46614e-05f6-421a-b6f4-d6f8760d643a	10
2638689	Inpefa 200 MG Oral Tablet	SY	1a46614e-05f6-421a-b6f4-d6f8760d643a	10
2638693	Inpefa 400 MG Oral Tablet	SY	1a46614e-05f6-421a-b6f4-d6f8760d643a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70183-241-30	70183024130	30 TABLET in 1 BOTTLE (70183-241-30)	30 tablet	2023-12-01	No	No	Current