ELTROMBOPAG

Product NDC: 82009-199
11-digit product format: 820090199
Labeler code: 82009
Product ID: 82009-199_5577641b-9b90-58c0-e063-6294a90adeeb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ELTROMBOPAG
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Quallent Pharmaceuticals Health LLC
Application: ANDA206788
Marketing category: ANDA
Marketing start: 2026-10-15
Substance: ELTROMBOPAG OLAMINE
Active strength: 25 mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 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 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206788-001	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17
A206788-002	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17
A206788-003	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17
A206788-004	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A206788-001	AB
A206788-002	AB
A206788-003	AB
A206788-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A206788-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206788-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206788-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206788-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206788-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206788-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206788-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206788-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206788-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206788-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206788-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206788-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206788-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206788-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206788-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206788-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206788-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206788-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206788-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206788-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206788-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206788-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206788-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206788-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206788-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206788-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206788-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206788-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206788-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206788-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206788-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206788-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A206788-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206788-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206788-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A206788-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206788-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206788-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206788-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206788-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206788-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206788-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206788-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206788-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206788-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206788-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206788-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206788-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206788-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206788-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206788-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206788-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206788-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206788-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206788-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206788-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206788-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206788-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206788-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206788-004	AB	1	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206788-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206788-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206788-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206788-004	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-001	PC	2025-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-002	PC	2025-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-003	PC	2025-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206788-004	PC	2025-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206788-001	PC	2025-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206788-002	PC	2025-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206788-003	PC	2025-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206788-004	PC	2025-11-09	`6a471c1ec25d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
ELTROMBOPAG	ELTROMBOPAG	XLCare Pharmaceuticals Inc.	9af1e314-91ca-4ebc-ac12-f9fddc6d7902	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206788 application number: ANDA206788
ELTROMBOPAG	ELTROMBOPAG	Camber Pharmaceuticals, Inc.	e913cd11-f5fb-4ebe-81c7-0c5626b52cfd	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206788 application number: ANDA206788

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4U07F515LG	ELTROMBOPAG OLAMINE	496775-62-3	ELTROMBOPAG OLAMINE
S56D65XJ9G	ELTROMBOPAG	496775-61-2	ELTROMBOPAG

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82009-199-30	82009019930	30 TABLET, FILM COATED in 1 BOTTLE (82009-199-30)	2026-10-15	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ELTROMBOPAG	Quallent Pharmaceuticals Health LLC \| Hetero Labs Limited, Vemagal	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	1