NDC codes

FDA NDC Directory
Product NDC (as listed)77338-307Labeler and product segments. Claims need a package NDC.
Product NDC at billing width77338-0307Add 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
77338-307-0277338030702773380307025 g in 1 PACKET (77338-307-02)Marketed from May 23, 2013
77338-307-03773380307037733803070328.3 g in 1 TUBE (77338-307-03)Marketed from May 23, 2013
77338-307-047733803070477338030704113 g in 1 TUBE (77338-307-04)Marketed from May 23, 2013
77338-307-057733803070577338030705425 g in 1 JAR (77338-307-05)Marketed from May 23, 2013

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)
Astonea Vitamin A and DSuffix: Vitamin A and D
Generic name (nonproprietary)
white petrolatum
Active ingredients
Petrolatum — 76 g/100g
Dosage form
Ointment
Route
Topical
Labeler
ASTONEA LABS PRIVATE LIMITEDNDC labeler code 77338
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 016
Marketing start
Listing expires
Identifiers
Product ID 77338-307_1bbb6d64-77d3-86e2-e063-6294a90abdc4SPL ID 1bbb6d64-77d3-86e2-e063-6294a90abdc4SPL set ID ef7c357b-5ff6-b9d7-e053-2a95a90a1dcfRxCUI 1049072UNII 4T6H12BN9U

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

NDC on a medical claim

N477338030702 followed by a unit qualifier and the quantity

Package 77338-0307-02. 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)

Uses ■ helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect from the drying effects of wind and cold weather ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash ■ with each diaper change, espicially at bedtime when exposure to wet diapers may be prolonged

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 77338-307

What is NDC 77338-307?
77338-307 is the product NDC for Astonea Vitamin A and D (white petrolatum), Petrolatum 76 g/100g ointment, listed with the FDA by ASTONEA LABS PRIVATE LIMITED. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Astonea Vitamin A and D (White Petrolatum).
What is the active ingredient?
Petrolatum.
Who is the labeler?
ASTONEA LABS PRIVATE LIMITED, NDC labeler code 77338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Astonea Vitamin A and D?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 016

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

FDA NDC Directory listings under M 016
ProductStrengthForm · routeLabelerProduct NDC
Barrier Balmcolloidal oatmeal balmOatmeal 1 g/100gSalveTopicalTubby Todd73088-305
Earthmed Lip Balm PineappleallantoinAllantoin .045 g/4.455gSalveTopicalEarthmed LLC82876-988
Welmedix HomeCare PRO Fragile Skin ProtectantpetrolatumPetrolatum 42 g/100gOintmentTopicalWelmedix LLC24330-413
Petroleumwhite petrolatumPetrolatum 1 g/gJellyTopicalH E B37808-015
Pure Petrolatum JellypetrolatumPetrolatum 100 g/100gJellyTopicalMY IMPORTS USA LLC51628-4600
A and DpetrolatumPetrolatum 76 g/100gOintmentTopicalSafetec of America, Inc.61010-4405
Dermatitis Face Balmcolloidal oatmealOatmeal 5 g/100gOintmentTopicalSkinfix, Inc.61328-121
McKesson Skin Protectantzinc oxideZinc oxide 50 mg/mLCreamTopicalMcKesson Medical-Surgical Inc.68599-5312
All Over Lavender Rosemarycolloidal oat ointmentOatmeal 1 g/100gOintmentTopicalTubby Todd73088-303
XIMONTH GLP-1 PatchesglycerinAcetyl hexapeptide-8 amide .006 mg/30mg; Rose oil .006 mg/30mgPatchTopicalShantou Ximonth Biotechnology Co., Ltd.84989-009
Deep Renewal Broad Spectrumdimethicone, avobenzone, homosalate, and octisalateDimethicone 2 g/100g + 3 more ingredientsStickTopicalBlistex Inc10157-1170
Skin Soothing Cream - Nut Freecolloidal oatmealOatmeal 1 mg/gCreamTopicalAllure Labs62742-4194
Lavender Scent Petroleumwhite petroleumPetrolatum 99.9 g/100gJellyTopicalJell Pharmaceuticals Pvt Ltd30400-514
Witch HazelWitch hazel 842 mg/mLLiquidTopicalEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-039
Eczema Dermatitis Relief Balmcolloidal oatmealOatmeal 5 g/100gCreamTopicalSkinfix, Inc.61328-112
Dovenourishing hand sanitizer sensitive skin 8hr moisturizationAlcohol 610 mg/mLGelTopicalConopco Inc. d/b/a/ Unilever64942-1996
Petroleum Skin Protectantwhite petrolatumPetrolatum 1 g/gJellyTopicalPharmacy Value Alliance, LLC68016-069
Sweet Cheeks Diaper Sprayerzinc oxide diaper paste sprayZinc oxide 14.9 g/100gSprayTopicalTubby Todd73088-304
Estrogen Estriol Cream5% estriolEstriol 5 g/100gCreamTopicalYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD83364-026
Earthmed FS massage oilallantoinAllantoin 1 g/108.48gOilTopicalEarthmed LLC82876-986

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