FDA.reportPublic FDA data

Glatiramer Acetate

Product NDC
82983-429
11-digit product format
829830429
Labeler code
82983
Product ID
82983-429_bd2ebc53-149c-420d-8986-3fe3c3aeec82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glatiramer acetate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
AJENAT PHARMACEUTICALS LLC
Application
ANDA213382
Marketing category
ANDA
Marketing start
2026-03-20
Substance
GLATIRAMER ACETATE
Active strength
20 mg/mL
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 42.

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
A213382-001GLATIRAMER ACETATEGLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2026-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213382-001AP

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 06:07:402026-07A213382-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2026-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213382-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2026-02-11011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213382-001GLATIRAMER ACETATE20MG/MLINJECTABLE / SUBCUTANEOUSAP2026-02-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213382-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213382-001AP1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213382-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Glatiramer Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLATIRAMER ACETATE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5M691HL4BOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1111641Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a573ffb-5dd7-43b7-8633-c69f303b1bbfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4ee46d8-7228-4160-88ad-868cc5abf72fProduct name520260223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82983-429-01Glatiramer Acetate1 mL in 1 SYRINGEINJECTION, SOLUTION12
82983-429-01Glatiramer Acetate1 in 1 BLISTER PACKINJECTION, SOLUTION12
82983-429-30Glatiramer Acetate30 in 1 CARTONINJECTION, SOLUTION302

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
Glatiramer AcetateGLATIRAMER ACETATEAJENAT PHARMACEUTICALS LLC7a573ffb-5dd7-43b7-8633-c69f303b1bbf2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213382
application number: ANDA213382
ndc (product): 82983-429

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111641glatiramer acetate 20 MG in 1 ML Prefilled SyringePSN7a573ffb-5dd7-43b7-8633-c69f303b1bbf2
11116411 ML glatiramer acetate 20 MG/ML Prefilled SyringeSCD7a573ffb-5dd7-43b7-8633-c69f303b1bbf2
1111641glatiramer acetate 20 MG per 1 ML Prefilled SyringeSY7a573ffb-5dd7-43b7-8633-c69f303b1bbf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82983-429-01829830429011 mL in 1 SYRINGE1 mlHistorical
82983-429-308298304293030 BLISTER PACK in 1 CARTON (82983-429-30) / 1 SYRINGE in 1 BLISTER PACK (82983-429-01) / 1 mL in 1 SYRINGE30 blister pack2026-03-20NoNoCurrent