Home NDC 0054-0045 Ipratropium Bromide
Product NDC 0054-0045
11-digit product format 000540045
Labeler code 0054
Product ID 0054-0045_c8dbb0db-5c00-4205-a765-d664117c4398
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ipratropium Bromide
Dosage form SPRAY
Route NASAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA076664
Marketing category ANDA
Marketing start 2003-11-05
Substance IPRATROPIUM BROMIDE
Active strength 21 ug/1
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076664-001 IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076664-001 AB
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 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076664-001 IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED / NASAL AB RS 2003-11-05 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 Ipratropium Bromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IPRATROPIUM BROMIDE 21 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J697UZ2A9J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797833 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 0054-0045-44 Ipratropium Bromide 1 in 1 CARTON SPRAY 1 13 0054-0045-44 Ipratropium Bromide 345 in 1 BOTTLE, SPRAY SPRAY 345 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IPRATROPIUM BROMIDE ACTIVE INGREDIENT J697UZ2A9J IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 IPRATROPIUM ACTIVE MOIETY GR88G0I6UL IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 EDETATE CALCIUM DISODIUM INACTIVE INGREDIENT 25IH6R4SGF IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) INACTIVE INGREDIENT 8136Y38GY5 IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9 WATER INACTIVE INGREDIENT 059QF0KO0R IPRATROPIUM BROMIDE SPRAY [ROXANE LABORATORIES, INC] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0045 IPRATROPIUM BROMIDE SPRAY [HIKMA PHARMACEUTICALS USA INC.] 13 Current NDC, Legacy NDC, 2 package rows 20240209_05c56190-e346-4674-a4f8-049ce632ce2d.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 Marketing start Marketing end Sample Exclude flag Status 0054-0045-44 00054004544 1 BOTTLE, SPRAY in 1 CARTON (0054-0045-44) / 345 SPRAY in 1 BOTTLE, SPRAY 2003-11-05 0000-00-00 No No Current