Pretomanid

Product NDC: 49502-476
11-digit product format: 495020476
Labeler code: 49502
Product ID: 49502-476_99ba96bb-da73-4082-bb81-c573f6019013
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pretomanid
Dosage form: TABLET
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA212862
Marketing category: NDA
Marketing start: 2019-11-07
Substance: PRETOMANID
Active strength: 200 mg/1
Pharmacologic classes: Antimycobacterial [EPC], Organic Anion Transporter 3 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49502-476		D	Discontinued by firm	2026-08-11
excluded package	package	49502-476	49502-476-28	D	Discontinued by firm	2026-08-11
excluded package	package	49502-476	49502-476-93	D	Discontinued by firm	2026-08-11

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 · 36 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49502-476-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49502-476-93	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49502-476-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49502-476-93	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49502-476-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49502-476-93	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49502-476-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49502-476-93	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49502-476-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49502-476-93	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49502-476-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49502-476-93	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49502-476-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49502-476-93	`302b2466d912…`	`e7b80fea0513…`
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	49502-476-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49502-476-93	`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	49502-476-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49502-476-93	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49502-476-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49502-476-93	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49502-476-28	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49502-476-93	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49502-476-28	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49502-476-93	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N212862-001	PRETOMANID	PRETOMANID	200MG	TABLET / ORAL		RLD, RS	2019-08-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212862-001	NCE	2024-08-14
N212862-001	ODE-253	2026-08-14
N212862-001	GAIN	2029-08-14

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212862-001	PRETOMANID	200MG	TABLET / ORAL	RLD, RS	2019-08-14	`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212862-001	NCE	2024-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212862-001	ODE-253	2026-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212862-001	GAIN	2029-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212862-001	NCE	2024-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212862-001	ODE-253	2026-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212862-001	GAIN	2029-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212862-001	NCE	2024-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212862-001	ODE-253	2026-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212862-001	GAIN	2029-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212862-001	NCE	2024-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212862-001	ODE-253	2026-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212862-001	GAIN	2029-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212862-001	NCE	2024-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212862-001	ODE-253	2026-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212862-001	GAIN	2029-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212862-001	NCE	2024-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212862-001	ODE-253	2026-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212862-001	GAIN	2029-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212862-001	NCE	2024-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212862-001	ODE-253	2026-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212862-001	GAIN	2029-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212862-001	NCE	2024-08-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212862-001	ODE-253	2026-08-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212862-001	GAIN	2029-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212862-001	NCE	2024-08-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212862-001	ODE-253	2026-08-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212862-001	GAIN	2029-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212862-001	NCE	2024-08-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212862-001	ODE-253	2026-08-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212862-001	GAIN	2029-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212862-001	NCE	2024-08-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212862-001	ODE-253	2026-08-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212862-001	GAIN	2029-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212862-001	NCE	2024-08-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212862-001	ODE-253	2026-08-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212862-001	GAIN	2029-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212862-001	NCE	2024-08-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212862-001	ODE-253	2026-08-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212862-001	GAIN	2029-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212862-001	NCE	2024-08-14	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRETOMANID	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2XOI31YC4N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2198370	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
f1906fc9-cb3c-4e13-8a4a-da76100c1bf3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
455fcb39-5071-40c0-9e85-28c1336854f2	Product name	1	20200128

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49502-476-14	Pretomanid	14 in 1 CARTON	TABLET	14	13
49502-476-26	Pretomanid	1 in 1 CARTON	TABLET	1	13
49502-476-26	Pretomanid	26 in 1 BOTTLE	TABLET	26	13
49502-476-29	Pretomanid	100 in 1 CARTON	TABLET	100	13
49502-476-32	Pretomanid	1 in 1 BLISTER PACK	TABLET	1	13
49502-476-33	Pretomanid	1 in 1 BLISTER PACK	TABLET	1	13
49502-476-72	Pretomanid	1 in 1 CARTON	TABLET	1	13
49502-476-72	Pretomanid	182 in 1 BOTTLE	TABLET	182	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49502-476-26	EA - Each	49502-476	d27a3da0-4e01-447d-9520-b16c66f1a990	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49502-476	PRETOMANID TABLET [VIATRIS SPECIALTY LLC]	13	Current NDC, Legacy NDC, 8 package rows	20250410_f1906fc9-cb3c-4e13-8a4a-da76100c1bf3.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
Pretomanid	PRETOMANID	Viatris Specialty LLC	f1906fc9-cb3c-4e13-8a4a-da76100c1bf3	2024-11-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212862 application number: NDA212862 ndc (product): 49502-476

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2XOI31YC4N	PRETOMANID	187235-37-6	PRETOMANID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2198370	pretomanid 200 MG Oral Tablet	PSN	f1906fc9-cb3c-4e13-8a4a-da76100c1bf3	13
2198370	pretomanid 200 MG Oral Tablet	SCD	f1906fc9-cb3c-4e13-8a4a-da76100c1bf3	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49502-476-14	49502047614	14 in 1 CARTON						Historical
49502-476-26	49502047626	1 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLE	1 bottle	2019-11-07	0000-00-00	No	No	Current
49502-476-29	49502047629	100 in 1 CARTON						Historical
49502-476-32	49502047632	1 in 1 BLISTER PACK						Historical
49502-476-33	49502047633	1 in 1 BLISTER PACK						Historical
49502-476-72	49502047672	1 in 1 CARTON						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pretomanid	Viatris Specialty LLC	2024-11-15	HUMAN PRESCRIPTION DRUG LABEL	13
Pretomanid	Mylan Specialty LP	2019-08-30	HUMAN PRESCRIPTION DRUG LABEL	2