Ergomar

Product NDC
81279-104
Requested package NDC
81279-104-20
11-digit product format
812790104
Labeler code
81279
Product ID
81279-104_2ef9fa55-cdc3-dc0a-e063-6394a90a0e5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergotamine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Pangea Pharmaceuticals LLC
Application
ANDA087693
Marketing category
ANDA
Marketing start
2025-02-03
Substance
ERGOTAMINE TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Ergotamine Derivative [EPC], Ergotamines [CS]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087693-001ERGOMARERGOTAMINE TARTRATE2MGTABLET / SUBLINGUALRS1983-02-24

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-243f01610625f2…
2019-09-15 20:21 UTC2019-09A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087693-001ERGOMAR2MGTABLET / SUBLINGUALRS1983-02-24cb3db0bc1861…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ergomar SublingualERGOTAMINE TARTRATEPangea Pharmaceuticals LLCa9582fdb-7ddd-4f69-aa7a-66247cdb8c922025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087693
application number: ANDA087693
ndc (package): 81279-104-20
ndc (product): 81279-104
ndc11 (package): 81279010420

Additional Listing Data#

Finished product
Yes
Brand name base
Ergomar
Brand name suffix
Sublingual
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERGOTAMINE TARTRATE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MRU5XH3B48Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293862Internal RxNorm lookup
1293864Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a9582fdb-7ddd-4f69-aa7a-66247cdb8c92Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
32fd258b-9140-42bc-be18-18756be615a0Product name120170614
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81279-104-03Ergomar Sublingual1 in 1 CARTONTABLET12
81279-104-03Ergomar Sublingual3 in 1 BLISTER PACKTABLET32
81279-104-20Ergomar Sublingual2 in 1 CARTONTABLET22
81279-104-20Ergomar Sublingual10 in 1 BLISTER PACKTABLET102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81279-104-20EA - Each81279-104cd97b7ec-8810-4cf5-97bc-004db72db11312025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81279-104ERGOMAR SUBLINGUAL (ERGOTAMINE TARTRATE) TABLET [PANGEA PHARMACEUTICALS LLC]2Current NDC, 4 package rows20250227_a9582fdb-7ddd-4f69-aa7a-66247cdb8c92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293864Ergomar 2 MG Sublingual TabletPSNa9582fdb-7ddd-4f69-aa7a-66247cdb8c922
1293862ergotamine tartrate 2 MG Sublingual TabletPSNa9582fdb-7ddd-4f69-aa7a-66247cdb8c922
1293864ergotamine tartrate 2 MG Sublingual Tablet [Ergomar]SBDa9582fdb-7ddd-4f69-aa7a-66247cdb8c922
1293862ergotamine tartrate 2 MG Sublingual TabletSCDa9582fdb-7ddd-4f69-aa7a-66247cdb8c922
1293864Ergomar 2 MG Sublingual TabletSYa9582fdb-7ddd-4f69-aa7a-66247cdb8c922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81279-104-20812790104202 BLISTER PACK in 1 CARTON (81279-104-20) / 10 TABLET in 1 BLISTER PACK2 blister pack2025-02-03NoNoCurrent