Eletriptan hydrobromide

Product NDC
31722-444
11-digit product format
317220444
Labeler code
31722
Product ID
31722-444_3d920aff-46bc-82ae-e063-6294a90a4222
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eletriptan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219143
Marketing category
ANDA
Marketing start
2025-07-07
Substance
ELETRIPTAN HYDROBROMIDE
Active strength
40 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219143-001ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2025-07-07
A219143-002ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2025-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219143-001AB
A219143-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219143-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2025-07-07caaa826d4ba7…
2026-08-18 06:07:402026-07A219143-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2025-07-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219143-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2025-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219143-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2025-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219143-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2025-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219143-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2025-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A219143-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2025-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219143-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2025-07-076a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219143-001ELETRIPTAN HYDROBROMIDEEQ 20MG BASETABLET / ORALAB2025-07-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219143-002ELETRIPTAN HYDROBROMIDEEQ 40MG BASETABLET / ORALAB2025-07-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219143-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219143-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219143-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219143-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219143-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219143-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219143-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A219143-002AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219143-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219143-002AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Eletriptan hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ELETRIPTAN HYDROBROMIDE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M41W832TA3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359493Internal RxNorm lookup
359494Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d412c0d-c8bd-498d-b57c-6626fb33147aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca727413-0b46-77de-6659-26418dfe7a5aProduct name620230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-444-31Eletriptan hydrobromide1 in 1 CARTONTABLET, FILM COATED11
31722-444-32Eletriptan hydrobromide6 in 1 BLISTER PACKTABLET, FILM COATED61
31722-444-33Eletriptan hydrobromide2 in 1 CARTONTABLET, FILM COATED21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-444-31EA - Each31722-444df7351bc-9850-44d5-bd1c-6f03a74981d112025-11-13
31722-444-32EA - Each31722-4448ed379a3-d8d4-45ff-9e9f-224e7167a2b112025-11-13

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eletriptan hydrobromideELETRIPTAN HYDROBROMIDECamber Pharmaceuticals, Inc.6d412c0d-c8bd-498d-b57c-6626fb33147a2025-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219143
application number: ANDA219143
ndc (product): 31722-444

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359493eletriptan HBr 20 MG Oral TabletPSN6d412c0d-c8bd-498d-b57c-6626fb33147a1
359494eletriptan HBr 40 MG Oral TabletPSN6d412c0d-c8bd-498d-b57c-6626fb33147a1
359493eletriptan 20 MG Oral TabletSCD6d412c0d-c8bd-498d-b57c-6626fb33147a1
359494eletriptan 40 MG Oral TabletSCD6d412c0d-c8bd-498d-b57c-6626fb33147a1
359493eletriptan 20 MG (as eletriptan HBr 24.2 MG) Oral TabletSY6d412c0d-c8bd-498d-b57c-6626fb33147a1
359494eletriptan 40 MG (as eletriptan HBr 48.5 MG) Oral TabletSY6d412c0d-c8bd-498d-b57c-6626fb33147a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-444-31317220444311 BLISTER PACK in 1 CARTON (31722-444-31) / 6 TABLET, FILM COATED in 1 BLISTER PACK (31722-444-32) 1 blister pack2025-07-07NoNoCurrent
31722-444-32317220444326 in 1 BLISTER PACKHistorical
31722-444-33317220444332 BLISTER PACK in 1 CARTON (31722-444-33) / 6 TABLET, FILM COATED in 1 BLISTER PACK (31722-444-32) 2 blister pack2025-07-07NoNoCurrent