Home NDC 0404-9962 Terbutaline Sulfate
Product NDC 0404-9962
11-digit product format 004049962
Labeler code 0404
Product ID 0404-9962_71e41b5f-46c2-4c2d-8f63-e164903d16f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terbutaline Sulfate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Henry Schein, Inc.
Application ANDA076887
Marketing category ANDA
Marketing start 2022-01-12
Marketing end 2027-03-01
Substance TERBUTALINE SULFATE
Active strength 1 mg/mL
NDC exclude flag No
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076887-001 TERBUTALINE SULFATE TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076887-001 AP
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 2 · 42 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 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Terbutaline Sulfate Active Ingredients# Ingredient, Strength table Ingredient Strength TERBUTALINE SULFATE 1 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857635 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 0404-9962-01 Terbutaline Sulfate 1 mL in 1 VIAL INJECTION, SOLUTION 1 6 0404-9962-01 Terbutaline Sulfate 1 in 1 BAG INJECTION, SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9962 TERBUTALINE SULFATE INJECTION, SOLUTION [HENRY SCHEIN, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20241018_9f4b177e-4d7d-4255-afeb-522c7d4594c6.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 0404-9962-01 00404996201 1 VIAL in 1 BAG (0404-9962-01) / 1 mL in 1 VIAL 1 vial 2022-01-12 2027-03-01 No No Current