Ipratropium Bromide and Albuterol Sulfate
- Product NDC
- 0185-7322
- 11-digit product format
- 001857322
- Labeler code
- 0185
- Product ID
- 0185-7322_033ee32c-9a53-4fdd-ac28-dddce389fb60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ipratropium bromide and albuterol sulfate
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Eon Labs, Inc.
- Application
- NDA020950
- Marketing category
- NDA
- Marketing start
- 2001-03-21
- Marketing end
- 0000-00-00
- Substance
- IPRATROPIUM BROMIDE; ALBUTEROL SULFATE
- Active strength
- 1 mg/3mL; mg/3mL
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36c | Product name | 2 | 20251106 |
| d953267a-4ca0-4d44-91ad-712cdee8ab38 | Product name | 2 | 20250630 |
| 26005090-31a1-441d-920b-db3101a55d53 | Product name | 3 | 20250221 |
| 1c39b897-7219-42a1-9f3a-ec86cfd7b04b | Product name | 3 | 20250218 |
| 0a278166-c8aa-41b6-b4a5-6ac332bde76a | Product name | 1 | 20230718 |
| c76bcd0f-25eb-471e-b970-1956c95c26c5 | Product name | 1 | 20230425 |
| 36390b75-5438-47d3-af60-732a654e9025 | Product name | 2 | 20220110 |
| 387afa72-0c5a-0d6b-ee2c-60c3506659e8 | Product name | 6 | 20210518 |
| 1b8ea3ec-88bd-98ea-c961-00ae340b5b14 | Product name | 2 | 20200220 |
| 3aa5a017-61e9-0c89-adef-13e7964d22f0 | Product name | 3 | 20171208 |
| 6ac73021-459f-435b-b6c5-8c7d6a50c021 | Product name | 2 | 20170404 |
| c3c27a99-b8bc-4955-841c-26555f58ee7e | Product name | 1 | 20150421 |
| bc98cf6f-a973-7162-5e30-0e7dd8c56bc3 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0185-7322-13 | ML - Milliliter | 0185-7322 | 8fc4e26e-ec2f-4e97-8540-86a9e18e3d26 | 1 | 2012-07-24 |
| 0185-7322-30 | ML - Milliliter | 0185-7322 | b84b5f12-4b7e-44a7-834b-5065a4b86190 | 1 | 2012-07-24 |
| 0185-7322-60 | ML - Milliliter | 0185-7322 | 9fbc8539-aaed-4404-a80d-5a53240d5b8a | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ACTIVE INGREDIENT | 021SEF3731 | IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| IPRATROPIUM BROMIDE | ACTIVE INGREDIENT | J697UZ2A9J | IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ALBUTEROL | ACTIVE MOIETY | QF8SVZ843E | IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| IPRATROPIUM | ACTIVE MOIETY | GR88G0I6UL | IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1437702 | ipratropium Br 0.5 MG / albuterol sulfate 3 MG in 3 ML Inhalation Solution | PSN | 8bcc115b-88da-4ff0-b4e1-ef10d5287e54 | 1 |
| 1437702 | albuterol 0.833 MG/ML / ipratropium bromide 0.167 MG/ML Inhalation Solution | SCD | 8bcc115b-88da-4ff0-b4e1-ef10d5287e54 | 1 |
| 1437702 | albuterol 2.5 MG (as albuterol sulfate 3 MG) / ipratropium bromide 0.5 MG per 3 ML Inhalation Solution | SY | 8bcc115b-88da-4ff0-b4e1-ef10d5287e54 | 1 |