Baclofen (intrathecal)

Product NDC
71525-010
11-digit product format
715250010
Labeler code
71525
Product ID
71525-010_66d85337-b4ad-403e-8631-3123311477b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
INJECTION
Route
INTRATHECAL
Labeler
Emerald International Limited
Application
ANDA091193
Marketing category
ANDA
Marketing start
2018-12-01
Marketing end
0000-00-00
Substance
BACLOFEN
Active strength
10 mg/20mL
Pharmacologic classes
GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71525-010IInactivated by FDA2026-09-14
excluded packagepackage71525-01071525-010-01IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71525-010-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71525-010-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71525-010-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71525-010-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71525-010-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71525-010-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71525-010-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71525-010-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71525-010-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71525-010-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71525-010-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71525-010-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71525-010-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71525-010-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71525-010-011332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091193-001BACLOFENBACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-03
A091193-002BACLOFENBACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-03
A091193-003BACLOFENBACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A091193-001AP
A091193-002AP
A091193-003AP

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-0384e616aacf4f…
2026-09-14 22:38:342026-08A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-0384e616aacf4f…
2026-09-14 22:38:342026-08A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-0384e616aacf4f…
2026-08-18 06:07:402026-07A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-03caaa826d4ba7…
2026-08-18 06:07:402026-07A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-03caaa826d4ba7…
2026-08-18 06:07:402026-07A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091193-002BACLOFEN0.5MG/MLINJECTABLE / INTRATHECALAP2016-05-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091193-003BACLOFEN2MG/MLINJECTABLE / INTRATHECALAP2016-05-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091193-001BACLOFEN0.05MG/MLINJECTABLE / INTRATHECALAP2016-05-03301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A091193-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A091193-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A091193-003AP184e616aacf4f…
2026-08-18 06:07:402026-07A091193-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A091193-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A091193-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091193-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091193-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091193-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091193-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091193-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091193-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091193-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091193-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091193-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091193-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091193-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091193-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091193-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091193-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091193-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091193-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091193-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091193-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091193-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091193-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091193-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091193-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091193-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091193-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091193-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091193-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091193-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091193-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091193-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091193-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091193-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091193-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091193-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091193-001AP1301d65b070ca…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71525-010-012023-01-30C16284748780-1f386c64a-087e-0266-e053-dadaa90a7c1aBaclofen Injection (Intrathecal)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71525-010-01Baclofen (intrathecal)1 in 1 BOXINJECTION12
71525-010-20Baclofen (intrathecal)20 mL in 1 AMPULEINJECTION202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71525-010BACLOFEN (INTRATHECAL) (BACLOFEN) INJECTION [EMERALD INTERNATIONAL LIMITED]2Legacy NDC, 2 package rows20181201_63c13374-f4d1-4437-a703-acb8211f2ae4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308516baclofen 0.05 MG in 1 ML (50 MCG/ML) InjectionPSN63c13374-f4d1-4437-a703-acb8211f2ae42
308517baclofen 10 MG in 20 ML (500 MCG/ML) InjectionPSN63c13374-f4d1-4437-a703-acb8211f2ae42
1666613baclofen 40 MG in 20 ML (2,000 MCG/ML) InjectionPSN63c13374-f4d1-4437-a703-acb8211f2ae42
3085161 ML baclofen 0.05 MG/ML InjectionSCD63c13374-f4d1-4437-a703-acb8211f2ae42
30851720 ML baclofen 0.5 MG/ML InjectionSCD63c13374-f4d1-4437-a703-acb8211f2ae42
166661320 ML baclofen 2 MG/ML InjectionSCD63c13374-f4d1-4437-a703-acb8211f2ae42
308516baclofen 0.05 MG per 1 ML InjectionSY63c13374-f4d1-4437-a703-acb8211f2ae42
308517baclofen 10,000 MCG per 20 ML InjectionSY63c13374-f4d1-4437-a703-acb8211f2ae42
1666613baclofen 40,000 MCG per 20 ML InjectionSY63c13374-f4d1-4437-a703-acb8211f2ae42
308516baclofen 50 MCG per 1 ML InjectionSY63c13374-f4d1-4437-a703-acb8211f2ae42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71525-010-01715250010011 AMPULE in 1 BOX (71525-010-01) > 20 mL in 1 AMPULE (71525-010-20) 1 ampule2018-12-010000-00-00NoNoCurrent
71525-010-207152500102020 mL in 1 AMPULE20 mlHistorical