FDA.reportPublic FDA data

Baclofen

Product NDC
71335-2767
11-digit product format
713352767
Labeler code
71335
Product ID
71335-2767_5bae76d2-2bf4-4353-ac07-0156403a7cf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212378
Marketing category
ANDA
Marketing start
2024-06-15
Substance
BACLOFEN
Active strength
10 mg/1
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui197391

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2767-0Baclofen112 in 1 BLISTER PACKTABLET1121
71335-2767-1Baclofen30 in 1 BLISTER PACKTABLET301
71335-2767-2Baclofen120 in 1 BLISTER PACKTABLET1201
71335-2767-3Baclofen20 in 1 BLISTER PACKTABLET201
71335-2767-4Baclofen60 in 1 BLISTER PACKTABLET601
71335-2767-5Baclofen100 in 1 BLISTER PACKTABLET1001
71335-2767-6Baclofen56 in 1 BLISTER PACKTABLET561
71335-2767-7Baclofen90 in 1 BLISTER PACKTABLET901
71335-2767-8Baclofen140 in 1 BLISTER PACKTABLET1401
71335-2767-9Baclofen84 in 1 BLISTER PACKTABLET841

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2767-0EA - Each71335-27675c1ed943-7580-4150-95e1-534c09e9863912026-04-20
71335-2767-1EA - Each71335-276782b844ba-6775-4110-92bb-013f876c262c12026-04-20
71335-2767-2EA - Each71335-276768443628-1295-4d87-8118-ba6a403e6f3c12026-04-20
71335-2767-3EA - Each71335-276755622083-4f38-4297-802c-0e67345c41e112026-04-20
71335-2767-4EA - Each71335-276708f68d5a-e2fe-432b-8444-df3848d6883712026-04-20
71335-2767-5EA - Each71335-276722ed2213-b4ad-48f4-b3db-1639d39bfea112026-04-20
71335-2767-6EA - Each71335-2767b2b7d444-b9b8-4bee-94e0-4de78e2b50ee12026-04-20
71335-2767-7EA - Each71335-276761ce5608-6692-4a53-a4ad-a958bcfb9bb212026-04-20
71335-2767-8EA - Each71335-276778f65f89-436c-4462-a6b3-222939b3f20012026-04-20
71335-2767-9EA - Each71335-2767ed0a15ee-2479-4476-beb7-fd39c5414edb12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN0a5940cd-63eb-4d1b-8e92-44df264bc05a1
197391baclofen 10 MG Oral TabletSCD0a5940cd-63eb-4d1b-8e92-44df264bc05a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2767-071335276700112 TABLET in 1 BLISTER PACK (71335-2767-0) 112 tablet2025-10-03NoNoHistorical
71335-2767-17133527670130 TABLET in 1 BLISTER PACK (71335-2767-1) 30 tablet2025-10-03NoNoHistorical
71335-2767-271335276702120 TABLET in 1 BLISTER PACK (71335-2767-2) 120 tablet2025-10-03NoNoHistorical
71335-2767-37133527670320 TABLET in 1 BLISTER PACK (71335-2767-3) 20 tablet2025-10-03NoNoHistorical
71335-2767-47133527670460 TABLET in 1 BLISTER PACK (71335-2767-4) 60 tablet2025-10-03NoNoHistorical
71335-2767-571335276705100 TABLET in 1 BLISTER PACK (71335-2767-5) 100 tablet2025-10-03NoNoHistorical
71335-2767-67133527670656 TABLET in 1 BLISTER PACK (71335-2767-6) 56 tablet2025-10-03NoNoHistorical
71335-2767-77133527670790 TABLET in 1 BLISTER PACK (71335-2767-7) 90 tablet2025-10-03NoNoHistorical
71335-2767-871335276708140 TABLET in 1 BLISTER PACK (71335-2767-8) 140 tablet2025-10-03NoNoHistorical
71335-2767-97133527670984 TABLET in 1 BLISTER PACK (71335-2767-9) 84 tablet2025-10-03NoNoHistorical