Home NDC 0115-2622 TERBUTALINE SULFATE
Product NDC 0115-2622
11-digit product format 001152622
Labeler code 0115
Product ID 0115-2622_63142944-3083-4d47-908f-2984144b6c5d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TERBUTALINE SULFATE
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA075877
Marketing category ANDA
Marketing start 2001-06-26
Substance TERBUTALINE SULFATE
Active strength 5 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0115-2622-03 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0115-2622-03 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0115-2622-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0115-2622-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0115-2622-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0115-2622-03 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0115-2622-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0115-2622-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0115-2622-03 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0115-2622-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0115-2622-02 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0115-2622-03 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0115-2622-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0115-2622-02 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0115-2622-03 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0115-2622-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0115-2622-02 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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 A075877-001 TERBUTALINE SULFATE TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 A075877-002 TERBUTALINE SULFATE TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26
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 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075877-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2001-06-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075877-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2001-06-26 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 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 0115-2622-01 TERBUTALINE SULFATE 100 in 1 BOTTLE TABLET 100 13 0115-2622-02 TERBUTALINE SULFATE 500 in 1 BOTTLE TABLET 500 13 0115-2622-03 TERBUTALINE SULFATE 1000 in 1 BOTTLE TABLET 1000 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TERBUTALINE SULFATE ACTIVE INGREDIENT 576PU70Y8E TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 2 TERBUTALINE ACTIVE MOIETY N8ONU3L3PG TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 2 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TERBUTALINE SULFATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-2622 TERBUTALINE SULFATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 11 Current NDC, Legacy NDC, 3 package rows 20250108_382dcebb-6e41-4335-818d-b5822e3fb884.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 · 1 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 0115-2622-01 00115262201 100 TABLET in 1 BOTTLE (0115-2622-01) 100 tablet 2001-06-26 0000-00-00 No No Current 0115-2622-02 00115262202 500 TABLET in 1 BOTTLE (0115-2622-02) 500 tablet 2001-06-26 0000-00-00 No No Current 0115-2622-03 00115262203 1000 TABLET in 1 BOTTLE (0115-2622-03) 1000 tablet 2001-06-26 0000-00-00 No No Current