Home NDC 0527-1330 Baclofen
Product NDC 0527-1330
11-digit product format 005271330
Labeler code 0527
Product ID 0527-1330_153f6bd7-9462-4d92-b738-48e7807c5919
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name baclofen
Dosage form TABLET
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA078220
Marketing category ANDA
Marketing start 2007-07-01
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 Source provenance: Browse the complete Orange Book source catalog .
Additional Listing Data#
Finished product Yes
Brand name base Baclofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACLOFEN 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H789N3FKE8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197391 Internal RxNorm lookup 197392 Internal RxNorm lookup 430902 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-1330-01 Baclofen 100 in 1 BOTTLE, PLASTIC TABLET 100 19 0527-1330-05 Baclofen 500 in 1 BOTTLE, PLASTIC TABLET 500 19 0527-1330-10 Baclofen 1000 in 1 BOTTLE, PLASTIC TABLET 1000 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [LANNETT COMPANY, INC.] 9 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [LANNETT COMPANY, INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [LANNETT COMPANY, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [LANNETT COMPANY, INC.] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [LANNETT COMPANY, INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BACLOFEN TABLET [LANNETT COMPANY, INC.] 9 BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [PROFICIENT RX LP] 2 BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.] 2 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [PROFICIENT RX LP] 2 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [PROFICIENT RX LP] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [PROFICIENT RX LP] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [PROFICIENT RX LP] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BACLOFEN (BACLOFEN) TABLET [AVKARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BACLOFEN TABLET [PROFICIENT RX LP] 2 BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [AMERICAN HEALTH PACKAGING] 1 BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [DIRECT RX] 1 BACLOFEN ACTIVE INGREDIENT H789N3FKE8 BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 1 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [AMERICAN HEALTH PACKAGING] 1 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [DIRECT RX] 1 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 1 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 BACLOFEN ACTIVE MOIETY H789N3FKE8 BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [AMERICAN HEALTH PACKAGING] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BACLOFEN TABLET [DIRECT RX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [DIRECT RX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [AMERICAN HEALTH PACKAGING] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [DIRECT RX] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BACLOFEN TABLET [DIRECT RX] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BACLOFEN TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BACLOFEN TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BACLOFEN TABLET [MAJOR PHARMACEUTICALS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BACLOFEN TABLET [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1330 BACLOFEN TABLET [LANNETT COMPANY, INC.] 19 Current NDC, Legacy NDC, 3 package rows 20210924_f84f3f4c-17e6-43f1-9600-63b0b175837b.zip
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 · 11 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Baclofen BACLOFEN Cardinal Health 107, LLC 2278954a-7605-426a-ae85-1bf0a3117420 2026-04-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220 Baclofen BACLOFEN Preferred Pharmaceuticals, Inc. 58416ceb-994f-4571-afbd-c2171823f528 2026-01-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220 Baclofen BACLOFEN Major Pharmaceuticals ae732bdc-5178-4565-8219-d1787a5211a6 2026-01-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220 Baclofen BACLOFEN PD-Rx Pharmaceuticals, Inc. cfcf519f-5d15-431d-89c8-961a0c38ba60 2025-10-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220 Baclofen BACLOFEN Bryant Ranch Prepack fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f 2024-01-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220 Baclofen BACLOFEN Bryant Ranch Prepack 402a0a2b-95a6-4d22-bedf-826e1f1cd2c3 2024-01-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220 Baclofen BACLOFEN Bryant Ranch Prepack 54bea140-c537-44a2-8d1d-bfb20471f4d8 2024-01-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220 Baclofen BACLOFEN Bryant Ranch Prepack 12d57610-8c70-4729-b358-56525613a29d 2024-01-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220 Baclofen BACLOFEN Bryant Ranch Prepack fded79a4-c354-448d-96dd-6dc69c46a013 2023-10-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220 Baclofen BACLOFEN Lannett Company, Inc. f84f3f4c-17e6-43f1-9600-63b0b175837b 2021-02-24 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220 ndc (product): 0527-1330 Baclofen BACLOFEN Aphena Pharma Solutions - Tennessee, LLC d9e5a8b9-1524-41b4-942f-f95015dd17f9 2020-08-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078220 application number: ANDA078220
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0527-1330-01 00527133001 100 TABLET in 1 BOTTLE, PLASTIC (0527-1330-01) 100 tablet 2007-07-01 0000-00-00 No No Current 0527-1330-05 00527133005 500 TABLET in 1 BOTTLE, PLASTIC (0527-1330-05) 500 tablet 2007-07-01 0000-00-00 No No Current 0527-1330-10 00527133010 1000 TABLET in 1 BOTTLE, PLASTIC (0527-1330-10) 1000 tablet 2007-07-01 0000-00-00 No No Current