Home NDC 0527-1318 Terbutaline Sulfate
Product NDC 0527-1318
11-digit product format 005271318
Labeler code 0527
Product ID 0527-1318_75d6b891-2c50-4748-829a-3567ee966978
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terbutaline Sulfate
Dosage form TABLET
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA077152
Marketing category ANDA
Marketing start 2005-03-25
Substance TERBUTALINE SULFATE
Active strength 2.5 mg/1
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077152-001 TERBUTALINE SULFATE TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 A077152-002 TERBUTALINE SULFATE TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Terbutaline Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERBUTALINE SULFATE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 576PU70Y8E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857677 Internal RxNorm lookup 857683 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-1318-01 Terbutaline Sulfate 100 in 1 BOTTLE TABLET 100 17 0527-1318-10 Terbutaline Sulfate 1000 in 1 BOTTLE TABLET 1000 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TERBUTALINE SULFATE ACTIVE INGREDIENT 576PU70Y8E TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] 11 TERBUTALINE ACTIVE MOIETY N8ONU3L3PG TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] 11 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] 11 POVIDONE INACTIVE INGREDIENT FZ989GH94E TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] 11 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] 11 TERBUTALINE SULFATE ACTIVE INGREDIENT 576PU70Y8E TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TERBUTALINE ACTIVE MOIETY N8ONU3L3PG TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TERBUTALINE SULFATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1318 TERBUTALINE SULFATE TABLET [LANNETT COMPANY, INC.] 17 Current NDC, Legacy NDC, 2 package rows 20240704_fbf54709-5857-4dbc-9233-ebd7abff88c8.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 · 2 matching rows.
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 0527-1318-01 00527131801 100 TABLET in 1 BOTTLE (0527-1318-01) 100 tablet 2005-03-25 0000-00-00 No No Current 0527-1318-10 00527131810 1000 TABLET in 1 BOTTLE (0527-1318-10) 1000 tablet 2005-03-25 0000-00-00 No No Current