NDC codes

FDA NDC Directory
Product NDC (as listed)76420-196Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0196Add 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
76420-196-0376420019603764200196031 TUBE in 1 CARTON (76420-196-03) / 3.5 g in 1 TUBEMarketed from Nov 30, 2021

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)
Erythromycin
Generic name (nonproprietary)
erythromycin
Active ingredients
Erythromycin — 5 mg/g
Dosage form
Ointment
Route
Ophthalmic
Labeler
Asclemed USA, Inc.NDC labeler code 76420
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 064067
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
Identifiers
Product ID 76420-196_d1fbbd69-37b7-7ae4-e053-2a95a90a8398SPL ID d1fbbd69-37b7-7ae4-e053-2a95a90a8398SPL set ID 7810e881-5130-4a94-b2e0-9f63f8a7a504RxCUI 310149UNII 63937KV33D
Pharmacologic class
Macrolide Antimicrobial; Macrolide

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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N476420019603 followed by a unit qualifier and the quantity

Package 76420-0196-03. 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)

INDICATIONS AND USAGE For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis . The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-196

What is NDC 76420-196?
76420-196 is the product NDC for Erythromycin, Erythromycin 5 mg/g ointment, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Erythromycin.
What is the active ingredient?
Erythromycin.
Who is the labeler?
Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Erythromycin?
68 other product NDCs are listed under this name. See all Erythromycin NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Erythromycin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ErythromycinErythromycin 5 mg/gOintmentOphthalmicSentiss Pharmaceuticals LLC70244-03170244-0031-0170244-0031-02
ErythromycinErythromycin 333 mg/1Tablet, Delayed releaseOralTorrent Pharmaceuticals Limited13668-58713668-0587-0113668-0587-0513668-0587-30
erythromycinErythromycin 250 mg/1Capsule, Delayed release pelletsOralDr. Reddy's Labratories Inc.75907-07675907-0076-01
ErythromycinErythromycin 5 mg/gOintmentOphthalmicST. MARY'S MEDICAL PARK PHARMACY60760-67060760-0670-35
ErythromycinErythromycin 5 mg/gOintmentOphthalmicRedpharm Drug67296-212867296-2128-03
ErythromycinErythromycin 5 mg/gOintmentOphthalmicNuCare Pharmaceuticals,Inc.68071-399268071-3992-02
ErythromycinErythromycin 5 mg/gOintmentOphthalmicARMAS PHARMACEUTICALS INC.72485-67072485-0670-3172485-0670-35
ErythromycinErythromycin 5 mg/gOintmentOphthalmicFera Pharmaceuticals, LLC48102-05748102-0057-11
ErythromycinErythromycin 250 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-39746708-0397-3046708-0397-3146708-0397-91
ErythromycinErythromycin 500 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-39846708-0398-3046708-0398-3146708-0398-91

All 69 Erythromycin NDCs

Other NDCs under ANDA 064067

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

FDA NDC Directory listings under ANDA 064067
ProductStrengthForm · routeLabelerProduct NDC
ErythromycinErythromycin 5 mg/gOintmentOphthalmicBausch & Lomb Incorporated24208-910
ErythromycinErythromycin 5 mg/gOintmentOphthalmicA-S Medication Solutions50090-1484
ErythromycinErythromycin 5 mg/gOintmentOphthalmicCardinal Health 107, LLC55154-7850
ErythromycinErythromycin 5 mg/gOintmentOphthalmicDirect Rx61919-090
ErythromycinErythromycin 5 mg/gOintmentOphthalmicProficient Rx LP63187-608
ErythromycinErythromycin 5 mg/gOintmentOphthalmicNuCare Pharmaceuticals,Inc.66267-975
ErythromycinErythromycin 5 mg/gOintmentOphthalmicNuCare Pharmaceuticals,Inc.68071-4228
ErythromycinErythromycin 5 mg/gOintmentOphthalmicPreferred Pharmaceuticals, Inc.68788-9328
ErythromycinErythromycin 5 mg/gOintmentOphthalmicREMEDYREPACK INC.70518-0465
ErythromycinErythromycin 5 mg/gOintmentOphthalmicSportpharm LLC85766-248

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