Prescription drug · ANDA

azithromycin dihydrate NDC 70436-228

Azithromycin dihydrate 200 mg/5mL · Powder, For suspension · Oral · Slate Run Pharmaceuticals, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)70436-228Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70436-0228Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70436-228-49704360228491 BOTTLE in 1 CARTON (70436-228-49) / 22.5 mL in 1 BOTTLEMarketed from Jun 7, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
azithromycin dihydrate
Generic name (nonproprietary)
azithromycin dihydrate
Active ingredients
Azithromycin dihydrate — 200 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217036
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 70436-228_32f66ed6-7a90-559b-e063-6394a90aaf93SPL ID 32f66ed6-7a90-559b-e063-6394a90aaf93SPL set ID 33d4ac05-b564-440c-971d-b78590dd2c32RxCUI 141963, 308459UNII 5FD1131I7S
Pharmacologic class
Macrolide Antimicrobial

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470436022849 followed by a unit qualifier and the quantity

Package 70436-0228-49. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration ( 2 )] Azithromycin for oral suspension is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1 ) Acute bacterial sinusitis in adults ( 1.1 ) Uncomplicated skin and skin structur…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217036

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217036
ProductStrengthForm · routeLabelerProduct NDC
azithromycin dihydrateAzithromycin dihydrate 100 mg/5mLPowder, For suspensionOralSlate Run Pharmaceuticals, LLC70436-220
azithromycin dihydrateAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralSlate Run Pharmaceuticals, LLC70436-221
azithromycin dihydrateAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralSlate Run Pharmaceuticals, LLC70436-222
AzithromycinAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralZhejiang Poly Pharm. Co., Ltd.72673-082
AzithromycinAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralZhejiang Poly Pharm. Co., Ltd.72673-081
AzithromycinAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralZhejiang Poly Pharm. Co., Ltd.72673-083
AzithromycinAzithromycin dihydrate 100 mg/5mLPowder, For suspensionOralZhejiang Poly Pharm. Co., Ltd.72673-084
AzithromycinAzithromycin dihydrate 100 mg/5mLPowder, For suspensionOralAiPing Pharmaceutical, Inc.11788-128
AzithromycinAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralAiPing Pharmaceutical, Inc.11788-129

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in
azithromycin dihydrate NDC 70436-228 | Med-Code